BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH PRO

    MDR report key: 4795620 · Received May 26, 2015

    Report

    Report Number
    3008585473-2015-00593
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 18, 2015
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    GZJ
    PMA / PMN Number
    K120398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT-1 WAS ADVISED BY THE DEVICE MANUFACTURER TO STOP USING THE DEVICE AND RETURN IT FOR EVALUATION USING THE MANUFACTURER PROVIDED SHIPPING CALL-TAG. THE MANUFACTURER RECEIVED THE DEVICE ALONG WITH THE HYDROGEL PADS DESIGNED FOR EXCLUSIVE USE WITH THE DEVICE. THE DEVICE APPEARANCE WAS NORMAL AND THE DEVICE EVALUATION SHOWED THE ELECTRICAL OUTPUT FOR THE DEVICE WAS TO SPECIFICATION. THE MANUFACTURING RECORD WAS EVALUATED IN THE INVESTIGATION PROCESS AND THE DEVICE PERFORMED TO SPECIFICATION WHEN IT WAS MANUFACTURED. THE MANUFACTURER PROVIDED AN EXPLANATION TO PT-1 IT APPEARS HE HAS THE TYPE OF SKIN THAT DOES NOT TOLERATE TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION. ADDITIONALLY, THE MANUFACTURER CONTACTED THE PRESCRIBING HEALTH CARE PROVIDER INFORMING PT-1 DOES NOT APPEAR TO TOLERATE TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION.

    Description of Event or Problem · 1

    I USED THE TENS FOR THE FIRST TIME, AND THE NEXT DAY I NOTICED MY BACK HAD BROKEN OUT IN A RASH WHERE THE GEL PADS WERE. I STOPPED USING THE DEVICE FOR ABOUT ONE MONTH, AND THEN I TRIED IT AGAIN AND THE RASH CAME BACK AFTER ONE DAY. SCARRING IS ON MY BACK THAT ITCHES AND WON'T GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339730 WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF GZJ HOLLYWOG, LLC 11.1500

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability