UNK NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-15 for UNK NI manufactured by Amfit.

Event Text Entries

[117692] Rptr writes: "i wish to file a formal complaint of consumer fraud and medical malpractice against the two companies who share joint responsibility for making me a pair of orthotics that are injurious to my feet and for refusing to either correct the error or refund my money. The crux of the problem is that" the specialty store "ordered me a pair of amfit orthotics that are not right for my feet and were not made according to the specs i asked for. The orthotics caused me tremendous pain, to the point that i was limping when i wore them and continued to hurt for several days after i removed them from my shoes. " store "refuses to correct the error and refuses to refund my money. " "amfit, the mfr, also refuses to do anything to resolve the problem. Further, one of" the specialty store "employees" "deliberately damaged my existing orthotics, refusing to restore them to their original condition and causing me intolerable foot and knee pain. I bought my first pair of amfit orthotics seven years ago. I've tried more than half a dozen orthotics in the last ten years. The amfit orthotics are the only ones that ever helped me and, in fact, i can't go without them. However, they are seven years old and falling apart. Believing that the store from which i bought them was no longer in business, i called amfit directly. A man "suggested that i go to" the specialty store. "i was fitted for the new orthotics on 10/17/98. " employee "told me that i could expect them within a week. However, more than a week passed and i didn't hear from her. When i finally called her, she told me that there had been a problem in the mfg process at amfit, causing amfit to turn out defective orthotics. That delayed delivery of my order. Employee further delayed delivery by telling me that she was "too busy to fit me in. " i would have to wait until n0v 6 to pick them up - a full 20 days after i paid for the orthotics, and nearly two weeks after i was supposed to get them. "the orthotics were uncomfortable the moment i put them on - something i never experienced seven years ago when i bought my first pair. There was a ridge on the right one that didn't match anything on my foot. It was a defect in either the design or the mfg process. However, because the orthotics are made of foam," employee "was able to grind it down to eliminate the ridge. It felt much better after that. The left orthotic was horrible. It was twice as thick on the outside edge as was the right orthotic. " the specialty store "insisted that i needed that much correction on my left foot and persuaded me, against my better judgement, to give it a try. I wore the new orthotics for a day and a half, during which time i was in terrible pain that only grew worse as time went by. My foot hurt in places that it never hurt before. Even after i removed the orthotics from my shoe, my foot continued to hurt for almost a week. I returned to" the specialty store "on saturday, 11/21 for an adjustment. (i waited that long for two reasons. One, i had to wait for the pain to subside before going back or i would be unable to give a fair evaluation to any adjustment that" employee " made for me. Two, i have to work during the week. " the store "takes a lot of time with their customers. I've never gotten out of the store in less than an hr and a half. I couldn't afford that time during the work week). " the store "made an adjustment for me, but it still wasn't right. My foot hurt the moment i put the shoe on - even before i put my foot on the floor. My foot hurt in a non-weight bearing position. My foot hurt when i walked on it. But" employee "again insisted that i needed that level of correction and that i should continue to try the orthotics. The left orthotic was so bad that driving away in my truck, with absolutely no pressure on my foot, my foot kept trying to pull away from the orthotic like pulling away from an itch i couldn't scratch. I tried walking around for a while, but it was only causing me to favor my left foot and to limp. It was causing me both foot and knee pain. So i removed the orthotic from my shoe once and for all. " the specialty store owner "refuses to accept that the orthotics are not right for my foot. She keeps insisting that i need that level of correction and that i have to give my foot time to adjust to the orthotic. Once again, i've worn amfit orthotics for seven years. I know how they are supposed to feel. I also know that an orthotic that causes me to limp and that hurst me in a non-weight bearing position is not right - no matter what" the store "says. I know the difference between a correction that i need to get used to and a poor prescription that will never be right for my feet. I've already had one podiatrist do permanent damage to my feet by providing something that wasn't right. " the owner "doesn't want to give me properly fitting orthotics because she thinks she can sell me shoes. She has repeatedly told me that the problem is my shoes, not her orthotics. She has specifically told me that i can't expect the orthotics to feel right until i buy "better" shoes or have my current shoes "rebalanced". "expletive deleted. " "if my seven-year-old orthotics feel great in my existing shoes, a new pair should feel even better. " the specialty store "is primarily a shoe store, specializing in very expensive shoes that are supposed to provide more foot support than shoes one can buy elsewhere. However, i've tried on some of" their "shoes. Not one of them was comfortable. Not one of them was right for my feet. But" owner "insisted i didn't know what i was talking about. After" the specialty store "refused to make the corrections i asked for, i called the mfr. It was a week and a half before i could make contact with amfit. " mfr "was on vacation when i first called, and i was told that no one else could help me.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002394
MDR Report Key202861
Date Received1998-12-15
Date of Report1998-12-09
Date Added to Maude1998-12-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameCUSTOM ORTHOTIC
Product CodeKYS
Date Received1998-12-15
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key197049
ManufacturerAMFIT
Manufacturer Address3004 KIFER ROAD SANTA CLARA CA * US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-12-15

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