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 Post subject: defective epipen
PostPosted: Tue Feb 27, 2007 11:16 am 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
I posted elsewhere about an epipen which did not autoinject when it was supposed to. I left the epi with the pharmacy---they called King Pharma, and they said they wanted to deal with me directly.

I called them today---they want me to send a letter along with the epipen autoinjector so they can analyze the problem. So far so good. But I asked whether a recall would be issued depending on their findings. The answer: no. They don't issue recalls. I alluded to a recall that was issued in 1998. She seemed surprised that I would know about that and a bit taken aback. They fixed that problem, she said . . . there was something wrong with the black head where the needle comes out. I asked about getting a refund. It is possible she said but it depends on their findings.

I thought they would for sure give me a refund automatically . . .after all, they are asking me to send the epipen to them. I also figured that they would assure me that they would issue a recall if there were a mechanical problem.

I had already tried to call Health Canada (am waiting to hear back from them). . . . I won't send the epi to King Pharma unless Health Canada isn't interested in investigating.


Last edited by Helen on Wed Feb 28, 2007 12:12 am, edited 1 time in total.

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 Post subject:
PostPosted: Tue Feb 27, 2007 11:22 am 
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Joined: Thu Mar 03, 2005 9:38 pm
Posts: 1643
Location: Toronto
Have you contacted the gov't yet?

Let us know the results.

_________________
self: allergy to sesame seeds and peanuts
3 sons each with at least one of the following allergies: peniciilin, sulfa-based antibiotic, latex, insect bites/stings


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 Post subject:
PostPosted: Wed Feb 28, 2007 12:07 am 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
Yeah, on Monday afternoon. It isn't easy to figure out whom to call. I'm waiting to hear back. Will keep you posted.


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 Post subject:
PostPosted: Wed Feb 28, 2007 7:43 am 
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Joined: Tue Mar 22, 2005 11:17 pm
Posts: 6456
Location: Ottawa
Good job Helen! :)
I hope you get action.

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Daughter: asthma, allergies to egg, milk, peanuts, tree nuts, most legumes (not soy) & penicillin. Developing hayfever type allergies.
Husband: no allergies
Me: allergies to some tree that flowers in May
Cat: allergic to beef, pork and lamb


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 Post subject:
PostPosted: Thu Mar 01, 2007 5:45 pm 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
Thanks, Susan. I called the main # again, and was referred to another inspector . . . this time my call was returned within 5 minutes!

The # I called is 1-800-268-9675 (this is the health products and food branch inspectorate)

then they referred me to a local office . . . I will mail the defective epi to the: "Medical Devices Unit" at Health Canada in Toronto.

I may have misjudged the person I spoke with at King Pharma----I let Health Canada know that the company had told me that they do not issue recalls. The inspector thought that maybe I was told that because if a recall were in order King Pharma would not in fact issue a recall . . . the manufacturer would.

I did call King Pharma back to let them know that I was mailing the epipen to Health Canada instead.

That conversation went a lot better than the first one--the company representative seemed concerned about the problem and as I wasn't sending a letter to them anymore, asked detailed questions about what happened, etc. (It is a clear case of the epipen not working---there is no exposed needle). As well, she looked into whether there have been any other complaints about this particular batch---there haven't been.


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 Post subject:
PostPosted: Fri Mar 02, 2007 7:51 am 
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Joined: Tue Mar 22, 2005 11:17 pm
Posts: 6456
Location: Ottawa
It's amazing how government attention will change a companies perspective on the problem, eh?
Oh, now, I'm just being cynical :roll:

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Moderator
Daughter: asthma, allergies to egg, milk, peanuts, tree nuts, most legumes (not soy) & penicillin. Developing hayfever type allergies.
Husband: no allergies
Me: allergies to some tree that flowers in May
Cat: allergic to beef, pork and lamb


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 Post subject:
PostPosted: Mon Mar 05, 2007 8:41 pm 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
Yeah, I wondered about the change, too. Part of it was that the company was expecting that I was going to send the epi to *them* along with a letter so they would have a second chance to investigate so I guess getting all the details from me over the phone wasn't as important. . . but ?

*If* Health Canada does send the epipen to the company like they said they probably would, I'm going to push the issue about getting a free replacement from the company.


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 Post subject:
PostPosted: Tue Mar 06, 2007 7:36 am 
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Joined: Tue Mar 22, 2005 11:17 pm
Posts: 6456
Location: Ottawa
I wonder how many autoinjectors are purchased as insurance but never used. I wonder what the failure rate is.

It seems to me that most items have a warrantee. You fork out good money for an item and you expect it to work under "normal use". I would certainly expect something that is going to save your life should operate or be refunded.

I hope you get results.

_________________
Moderator
Daughter: asthma, allergies to egg, milk, peanuts, tree nuts, most legumes (not soy) & penicillin. Developing hayfever type allergies.
Husband: no allergies
Me: allergies to some tree that flowers in May
Cat: allergic to beef, pork and lamb


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 Post subject:
PostPosted: Thu Mar 22, 2007 2:47 pm 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
Update: I sent the defective epi to the gov't . . . they sent the epi to King Pharma and the epi goes from there to the manufacturer.

I was impressed with how quickly Health Canada moved on the issue . . .they immediately sent me a letter confirming that they had received it. And I got an email explaining that they had looked at the epi and that they were sending it on to be examined by the company. they said something about also in the meantime looking at other recent batches and "any other" complaints they had received about recent batches. They didn't confirm that there were other complaints. Just that they would look at them if there were(?)

I called King Pharma today. I asked about how I might go about requesting a refund. I was told it would depend on what was in the manufacturer's report. I pointed out that they had received the product and could see that it hadn't worked properly . . . they agreed but said they can do nothing till they here from the manufacturer. *not impressed*

am thinking of switching to twinject in the future.


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 Post subject:
PostPosted: Thu Mar 22, 2007 3:46 pm 
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Joined: Sat Apr 16, 2005 12:09 am
Posts: 1054
Helen wrote:
. . . they agreed but said they can do nothing till they here from the manufacturer. *not impressed*

Given the history of your situation and the fact that Health Canada is involved... that is really poor customer service. Do they honestly think you purposely manipulated the Epi so that it could *appear* defective -- and why? Just so you could get a replacement? Why are they so careful to provide a replacement? That would leave such a poor taste in my mouth! Helen, did you try asking to speak with someone in a higher position? Once they were in possession of your Epi, they should have automatically sent you out a replacement.


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 Post subject:
PostPosted: Sat Mar 24, 2007 8:16 pm 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
No, I didn't ask to speak to anyone else. I really should have.

I don't see how they could suspect tampering----they confirmed that they have seen the epipen and that the needle was not exposed. (the grey cap is off.)

I wonder if it has something to do with company policy. Maybe it is just a blanket rule--no refunds unless the manufacturer has seen the defective device. If so, they need a new policy! Perhaps if they give me a refund it is tantamount to admitting that it is defective. and then they could be flooded with requests to have epis from that batch exchanged? I don't know. Just guessing.

In any case, King Pharma doesn't come off looking very good.


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 Post subject:
PostPosted: Sun Apr 29, 2007 6:26 pm 
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Joined: Tue Mar 22, 2005 6:53 pm
Posts: 1454
Location: Canada
My apologies for taking so long to get back to everyone on this issue. I did hear back from Health Canada on April 5. The conclusion of the investigation: the epipen was not defective; the consumer did not use enough force. Obviously, I'm rather skeptical about the results of this investigation, but there isn't really anything else that can be done at this point. I did email Health Canada (but I just got around to doing so today!), and I also forwarded a copy of the email to anaphylaxis Canada (also today). I guess I could lay on official complaint with King Pharma, but I feel I'd just be wasting my breath. I haven't been offered a refund.

I'll excerpt from my email from Health Canada:

Quote:
The investigation into this complaint is now complete and is considered
closed. The failed unit was tested and fully disassembled and examined by
Meridian Medical Technologies, the fabricator of the product. The
functionality test that was conducted found that the activation force
required to fire the unit (in this case, 5.50 lbs) fell within the
specification range of between 2.0 and 8.0 lbs. When the injector was
disassembled and examined, there was no evidence that the needle had hit
any other component before exiting the sheath. In all respects, the unit
appeared normal.

As part of the complaint follow-up, Health Canada has also reviewed the
complaint history for this lot (no other complaints have been received),
and for this product since 2003, and can find no indication of either a
lot-specific concern or of any trend with respect to the types or
frequency of complaints. While it may not seem a very satisfactory answer,
the company's conclusion that "there is always a chance that an injector
may require a little more force to activate that what (sic) the customer
may think or presume" is the only conclusion available based on these
findings.

Thank you for bringing this matter to the attention of Health Canada.
Should you have any questions or concerns, please do not hesitate to
contact me directly.


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 Post subject:
PostPosted: Mon Apr 30, 2007 6:57 am 
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Site Admin

Joined: Tue Mar 22, 2005 11:17 pm
Posts: 6456
Location: Ottawa
8.0 lbs of force seems like a lot on a small leg! :(

_________________
Moderator
Daughter: asthma, allergies to egg, milk, peanuts, tree nuts, most legumes (not soy) & penicillin. Developing hayfever type allergies.
Husband: no allergies
Me: allergies to some tree that flowers in May
Cat: allergic to beef, pork and lamb


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 Post subject:
PostPosted: Mon Apr 30, 2007 9:30 am 
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Joined: Mon Sep 11, 2006 1:13 am
Posts: 28
Location: Medicine Hat, Alberta
As a person who works in retail i find it appalling that they would not give you a refund or a brand new epi pen. As i said i work in retail and you generally try to keep the customer happy and with the stuff i deal with it is not life threatening. I would think they have your epi pen the least they could do is to give you a replacement considering that the medication in the pen is life saving. I guess customer satisfaction is not what they are going for.

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Daughter Ana to Cashews, Pistachios


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 Post subject:
PostPosted: Mon Apr 30, 2007 10:34 am 
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Joined: Sat Apr 16, 2005 12:09 am
Posts: 1054
I was thinking the same thing -- even if they don't consider the Epipen defective, seeing that the medication wasn't injected -- it just seems they could have at least replaced it as a "good will gesture". Terrible customer service in my opinion.


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