BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH PRO

    MDR report key: 8796178 · Received July 16, 2019

    Report

    Report Number
    3008585473-2019-00003
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    April 9, 2018
    Report Date
    July 16, 2019
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    PMA / PMN Number
    K171599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND ON THE INTERNET DURING POSTMARKET SURVEILLANCE OF ANONYMOUS CUSTOMER REVIEWS WITH LIMITED INFORMATION PROVIDED FOR AN INVESTIGATION.

    Description of Event or Problem · 1

    THESE ARE THIN. THEY DON'T ADHERE WELL. AND, THEY ARE SO UNEVEN THAT YOU END UP WITH HORRIBLE SHOOTING PAINS IN SOME AREAS WHILE USING THEM. I APPRECIATE THE PRICE, BUT VERY UNHAPPY THAT THEY'RE NOT RETURNABLE. THEIR INCONSISTENCY MAKES THEM UNUSABLE FOR ME. I DON'T RECOMMEND THESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590491 WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR NUH HOLLYWOG, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability