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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE WAVE LIFE WAVE PATCHES

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LIFE WAVE LIFE WAVE PATCHES Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem Pain (1994)
Event Date 12/21/2011
Event Type  Injury  
Event Description

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.

 
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Brand NameLIFE WAVE
Type of DeviceLIFE WAVE PATCHES
MDR Report Key2514308
MDR Text Key14889139
Report NumberMW5024842
Device Sequence Number1
Product Code BWK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 03/28/2012 Patient Sequence Number: 1
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