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EPI-PEN EXPLOSION

30 replies [Last post]
By domesticgodess on Fri, 09-15-06, 15:49

On Wednesday my sons brand new Epi-Pen exploded in his fanny pack in his backpack. For no reason.

Here is the letter I wrote to send with the Epi-Pen back to the makers.

To whom it may concern;

On September 13, 2006 my son went into his fanny pack to retrieve his Epi-Pen* and other medications. When he opened his fanny pack he noticed the casing for the Epi-Pen* was filled with a brown liquid. He immediately took this to his teacher who called me to come and get it.

When I arrived at the school the Public Health Nurse Erin Wilcox from the London and Middlesex Health unit was there. She did not understand why this Epi-Pen* had appeared to have exploded. Nor did I. The casing is intact. The Epi-Pen* itself appears to be intact yet empty.

I took it down to the pharmacy where I got it on September 6, 2006. The pharmacist there did not understand how this could have happened. He then contacted the makers of Epi in Kanata, Ontario.

The pharmacist explained to the representative what I had explained to him. He then told me that she would like to speak to me. She went on to explain that it was

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By Corvallis Mom on Fri, 09-15-06, 16:18

[img]http://uumor.pair.com/nutalle2/peanutallergy/eek.gif[/img] WOW.

How scary. This is a great reminder for those of us who have a bag we rarely take the epi-pens out of, however--

CHECK THEM REGULARLY.

(shudder) I can't bear to think about what would happen if you needed one and this had happened.

Please let us know what sort of resolution you get to this matter.

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By ajas_folks on Fri, 09-15-06, 18:26

EEEEK!

Note to self to also regularly check our Epi-pens kept at DS's school.

Sure would like to know what happened . . . am wondering if you will ever find out or if company will take any responsibility.

Please keep us posted as to company's response!

~Elizabeth

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By Momcat on Fri, 09-15-06, 19:19

Epipens have a glass vial inside??? I didn't realize that.

Cathy

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By domesticgodess on Fri, 09-15-06, 19:45

Okay, so I heard from Dey. Am going to call them back now. Will post what they have to say.

Apparently, from what she told me and I quote "he had to have stomped on it to break the glass tube".

Meaning the actual Epi-Pen is glass? Here for the last 9 years I thought it was plastic.

She was just ignorant and refused to even hear or admit that there must be a problem.

Even if my son did drop it from his whopping 4'3 if it breaks that easy there is a huge design flaw. But I have dropped it several times and even flung it out onto the road a few times. The old cases bottoms would fall off and I'd be carrying it and forget and it would fly out. They did not break. I took the new one and purposely dropped it from above my head right in the office of the school. Didn't break.

To think he was tossing it around the playground and no teacher noticed this? Uh-huh!!

We'll see. The only reason I came back here was because it would be terrible to reach for a life saver to find it empty.

~Jenna

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By domesticgodess on Fri, 09-15-06, 20:07

Okay, the lady I spoke to was very nice. She asked who I spoke to and then told me that Dey has actually pulled their products from this company (distribution company) because of the exact reason I was calling about. Poor customer service.

She thanked me for calling her and not standing for that treatment [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]

She asked me to mail the defective Epi to Dey in California. Which of course I will do. Gave me her name direct line and asked that I make it out to be sent to her direct. Very helpful.

She said they will likely replace the free one I got directly to the pharmacy. I am super impressed with her customer service. She even asked if it was found during a time of crisis. Which it was not. She asked what it was used for and had I had to depend on them in the past. Which of course I answered and yes I've used them to save his life before.

I am impressed. [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]

~Jenna

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By Corvallis Mom on Fri, 09-15-06, 21:05

That's great to hear! [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Good for you in not listening to that nasty CSR at the distribution company. I'm glad they're being so cooperative at Dey.

Of course, the larger concern is that this might be a manufacturing problem of some sort... are they going to let you know if they find any reason why this might have happened?

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By gvmom on Fri, 09-15-06, 23:13

Hi Jenna --

That really sucks that this happened -- and really very dangerous. I've talked with people at the Dey location in CA before, and they were really nice. Very helpful. I hope they'll be able to figure out why your Epi exploded. I was trying to think why they couldn't have the inner part of the pen be a hard molded plastic like the outer part of it, but it probably isn't feasible for the stability of the medication. It's funny, I never really even thought about how the actual epinephrine was contained within the pen itself.

If they get back to you about the cause, or even if it was some freak thing, let us know.

Glad your son wasn't going to get it for an emergency! Very lucky......

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By Jimmy's mom on Fri, 09-15-06, 23:49

If you haven't sent it yet (or if you saved the info) could you let us know the lot #? Just in case it is a manufaturing problem, it would be nice to have a heads-up.

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By domesticgodess on Sat, 09-16-06, 02:21

Some of you are familiar with me. I haven't been here in ages. I only came back because I do think about our kids.

In no way did I want to start a panic. Nor am I complaing about EPI-PEN. I am just trying to make everyone aware, so that no one falls into the complacency trap. Lull themselves into thinking we are okay just because we got the prescription filled and it is in a carrier,belt,fanny pack or whatever the means of transportation.

The lot # is 6cm391.

The chances of anyone else having the same lot number as mine are so very slim. Please don't panic. Just check you Epi's over for breakage,leakage or any kind of damage at all and replace it.

If it hadn't have been brand new I would have just replaced it and said nothing. I only brought it up because it was brand new and in a new and improved case.

Just my luck really.

~Jenna

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By cynde on Sat, 09-16-06, 04:40

Jenna, thank you so much for posting, I just checked our brand new epi's and 1 of the 3 has the exact same lot #. It is the one that I keep in my purse.

DS wears two, they are not the same lot # but but I will do a monthly (or maybe a weekly) check from now on.

Can you please keep me posted as to Deys findings when you get them.

Thank you so much.

Cynde

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By domesticgodess on Sun, 09-17-06, 17:40

WOW!! I thought how strange!!!! But then I looked in your profile and see you are in Canada. So am I so I guess that's not to strange.

It will probably take a very long time for them to study it. It will probably take over a week just for them to recieve it.

If you have benefits (I don't) I would see if you can get a different one. Say you lost one of them and want to replace it. Not a stretch really. Stranger things have happened.

I asked my brother to check his (beesting) and he lives in the same city and got them filled last week and his don't match mine.

What are the odds?

~Jenna

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By cynde on Sun, 09-17-06, 19:21

Since it is the one I keep in my purse I can check it daily very easily. I will wait until I what Dey says before I replace it.

We do have medical coverage thank goodness, but I hate to take advantage if I don't need to.

I have told DH about the experience you had and we decided that a weekly check of DS's epe-belt is something we need to start.

Thank you and please keep me posted.

Cynde

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By cynde on Thu, 09-21-06, 04:48

Hi, just checked DS's back-up epi in the school office, and that has the same lot # as well. I got 3 new ones at the same time, and 2 had the same lot #.

I think I will contact Dey directly to see what they have to say about what I should do.

Cynde

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By domesticgodess on Thu, 09-21-06, 15:53

Isn't it strange that the ones you have are okay?

But really it is just my luck to have something like that happen. If is going to happen it does to me. I have no idea why.

I mailed it out on Monday. I was just thinking that I gave her the Lot # and I am sure they have Epi's with that lot # and are looking into wether they need to do a recall or not. So I would sit tight and wait. This is a company that deals with life saving products so I am sure they are not dragging their feet on it like say maybe a stroller company or something that is essential.

It is unlikely that they even have mine yet. Sit tight Cynde. If you've already called them, what did they say?

~Jenna

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By Flounder on Thu, 09-21-06, 17:10

I also have an epi from that exact same lot! I almost didn't look thinking what are the chances...it is also new and expires in Nov 07. I filled it at a Shoppers.

Please keep me posted if anything comes up. Where would I find out about a recall?

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By domesticgodess on Thu, 09-21-06, 18:43

You will hear about it on the news for sure. It would be a huge issue. So maybe all Epi's made to expire in Nov.07' are the same lot number?

But you will hear aboutit on the news. I doubt highly that they will be recalled though.

~Jenna

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By solarflare on Thu, 09-21-06, 20:46

The ones I keep at the school for Jason have the same expiration date, but are a twin pack. Not sure about lot numbers though.

DH is going to check them for me when he picks up the kids.

------------------
Cheryl, mom to Jason (9 MFA including peanuts, tree nuts, shellfish and egg)
Joey (7 NKA)
Allison (3 MFA including milk, butternut squash, several fruits and suspected shellfish allergies, avoiding tree nuts, RAST - for peanut)
Ryan (born 12/27/05) nka *knock on wood*

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By smack on Fri, 09-22-06, 21:52

Hi Jennifer!!!!

I just had 2 refilled and the LOT 6CM391 Nov 07 for both.

I have to renew them in batches so I have to wait for another month then order 2 more as insurance only covers 2 a month.

So, probably they will end up being the same but I'll let you know.

Take care

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By cynde on Fri, 09-22-06, 21:53

Jenna, I was trying to contact Dey, but cannot find any contact info for them. I threw away the boxes that the epis came in and there is no phone # or contact info (not even a place to e-mail questions to them) on their website. How did you get a hold of them?

Cynde

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By domesticgodess on Fri, 09-22-06, 22:46

I googled them and called them direct. No, 800 number. I just looked for the contact us link.

Smack, did your kids get put on the balanced school day? They have two 1 hour breaks instead of 2 15 minute recesses and one hour lunch?

If you get a thing in your kids backpacks asking how you would feel or a thing saying they are having an information session on it, go to it and vote NO. It sucks. I can't believe our school did it without our permission. They said they sent stuff home but nothing came in either of my kids backpacks regarding it.

It has cost me 3 times as much in lunches as it did. Now my kids can't come home for lunch either.

To make matters worse they send the kids out to play for 40 minutes and then bring them into eat for the last 20 minutes.

Just sucks [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]

~Jenna

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By cynde on Fri, 09-22-06, 22:56

Jenna, sorry but I did not find any contact us links on the website. Do you still have the phone #?

Cynde

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By gvmom on Fri, 09-22-06, 23:07

The guy that I talked to at Dey about info & trainers was named Tony Gagarin (customer service rep).

The 800 number I have on his business card is: 1-800-755-5560

He is located at the Dey office in Napa (California).

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By cynde on Fri, 09-22-06, 23:32

Thank you, I'll give him a call.

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By smack on Sat, 09-23-06, 17:55

Jenna,

The kids started the balanced school day in September and don't come home for lunch anymore.
They eat for 20 minutes then go out for recess for 20 minutes. This happens at 10:45-11:25, then at 1:00 - 1:40. They are let out now at 3:20 instead of before which was 3:30. They are really loving this and plus they appreciate me a lot more now they don't see me until I pick them up.
I hope to find a job from around 9:30-2:30 but until that happens, I'm still at home.

TTYL
I do try to come and read a little here but don't find my issues are the same anymore now that the twins are 9. Austin does go to the allergist in January(they wanted him sooner but you have to give up the anti-histamines for a week and his environmental are bad so I waited till I knew he could survive)
The hospital has all moved around since we were there last so we have to go to his appointment first, then change hospitals for the blood work.
Thanks for the posting and heads up about the epipens, I will check this post for any updates.

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By domesticgodess on Sat, 09-30-06, 19:48

I got a postcard from day acknowledging my call and requesting the Epi be sent back. Which I'd already done. But I'm sure it will take weeks to get there.

Then I got a call from the first company I called. Allerex. Spoke to a woman there who'd been called by Dey. I asked if she was made aware of the ignorant treatment I received and did she know that is why I contacted Dey? She did, they told her. [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]

Smack:

I hate the balanced day. They are out for 10:15 to 11:15 they play first eat second. Backwards [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]

Then they get out at 1:05-2:05 again play then eat.

I drop Jason off at kindergarten at 5 to 1 and then pick the other up? Ah, no!! Now, he stays. I cherish those 2 hours I had to myself. They tried telling me Bryson could still come home and encouraged it as they are still trying to cut the amount of kids who stay for lunch. I told them to go back to the old way. Now they have no children who go home for lunch. Not my problem.

They still get out at 3:30.

You see Dr.Payton right? He moved? We don't see him anymore because he couldn't get a handle on Bryson. After 7 years of seeing him he sent us to Dr.Lyttle. Who does have a fantastic handle on both allergies an the asthma.

~Jenna

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By smack on Thu, 10-26-06, 15:12

Well I just picked up 2 more and the Exp date is Jan 08 and LOT 6CM546 so in one month everything did change.

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By cynde on Mon, 12-11-06, 06:48

Any word yet from dey?

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By domesticgodess on Mon, 12-11-06, 16:25

I got a letter from King Pharma Canada last Thrusday. But with Christmas stuff I am just getting the chance to post it now.

It states that all appropriate parts were examined. Upon examination it was discovered that the glass cartridge was broken across the neck, which allowed the drug solution to escape and then discolor when it came into contact with air.

We feel confident that the injector returned to us for evaluation did not leave the facility with a broken glass cartridge. There are too many checks and double checks to allow such a unit to elude detection. More than likely, the injector was damaged in subsequent handling after it left our control.

We are committed to quality assurance and we appreciate you bringing this matter to our attention.

They did send a replacement to my pharmacy for the one that they replaced to me back in September. They sent that to the pharmacy back in October. They were very speedy about that. Except I didn't know until just now when I called them to ask what replacement Epi they were referring to in this letter.

They are basically covering their ass. Remember this Epi was only a week old when it was broken and I don't even know for sure when it was broken. It was found in my son's fanny pack exactly a week after I bought it.

I am satisfied though. I have a replacement and I have gone since my son was 9 months old until his 11th birthday (when it was found) with no incidences. To have a fluke like this happen really is just that, a fluke. Good long stretch with none.

They were very speedy about it, and co-opretive so I can't complain.

I definetly will be checking his epi's like never before. I had actually never checked them in the past. I knew the expirtation dates and just replaced them.

~Jenna

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By Momcat on Mon, 12-11-06, 17:00

Maybe a manufacturing defect created a weak spot in the glass, but it didn't actually break until after you got it.

After reading this thread, I have decided to check the epipens we have more regularly.

Cathy

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By 3xy1PAinNH on Thu, 06-14-07, 03:08

I had the exact same thing happen this Fall, but didn't post about it. I had my son's epis in a bag in a backpack. I took them out and noticed they were wet. There was a brown discharge on the pens.

I contacted Dey, and returned it. They ended up telling me there was an unidentifable brown liquid on the outside of the epi, but the epi was not damaged.

In retrospect I should have sent both epis, I only sent the one...it might have been an issue with the other.

[This message has been edited by 3xy1PAinNH (edited June 13, 2007).]

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