LIFE WAVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-28 for LIFE WAVE manufactured by .

Event Text Entries

[14889139] A friend is a (b)(4) distributor and since i have a damaged trigeminal nerve, she thought the patches her company manufactures could help reduce my pain. I went with her to meeting which turned out to be a sales meeting, met her supervisor (b)(4), and learned a bit about the patches. I bought some patches and she gave me some of her own to try, but i received faulty info on how to use them. As a result, within a couple of days, the nerve pain flares up very badly. I had been on a lower dose of my medication prior to the flare and had very little break through pain, but after the improper use of the patches, the pain was constant and i had to increase my dosage about 70% to get the pain under control. It is now months later and i have still not been able to go back to the pre-event dosage. I complained to the company that they are sending distributors out into the fields to sell patches to people, but that they do not have enough training to do it properly and i was hurt. They never had informed consent, that there could be adverse reactions. I hope no one else gets hurt like i did. By the way, the company refunded me for my purchase.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024842
MDR Report Key2514308
Date Received2012-03-28
Date of Report2012-03-28
Date of Event2011-12-21
Date Added to Maude2012-04-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIFE WAVE
Generic NameLIFE WAVE PATCHES
Product CodeBWK
Date Received2012-03-28
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-03-28

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