BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE WAVE

    MDR report key: 2514308 · Received March 28, 2012

    Report

    Report Number
    MW5024842
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    December 21, 2011
    Report Date
    March 28, 2012
    Product Code
    BWK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE WAVE LIFE WAVE PATCHES BWK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other