BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH

    MDR report key: 5854562 · Received August 8, 2016

    Report

    Report Number
    3008585473-2016-00614
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    June 1, 2016
    Report Date
    August 8, 2016
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    PMA / PMN Number
    K120500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION OF THE OUTPUT WAVEFORMS: STAGE 1, STAGE 2 AND STAGE 3 (ALL STAGES) FUNCTION AS INTENDED TO DESIGN SPECIFICATION. DEVICE PERFORMED AND FUNCTIONED TO SPECIFICATION.

    Description of Event or Problem · 1

    ON TWO SEPARATE OCCASIONS I EXPERIENCED HIVES/WELTS PREDOMINATELY ON THE RIGHT SIDE OF MY LOWER BACK, BUT WASN'T A BIG ISSUE. THE FIRST OCCASION WAS WORSE THAN THE SECOND WITH MORE HIVES/WELTS. I CLEANSED MY SKIN WITH ALCOHOL BEFORE EACH USE. I INTERMITTENTLY FELT A HIGHER INTENSITY OUTPUT ON THE RIGHT SIDE, IT ALMOST ALWAYS SEEMED TO OCCUR AFTER I POWERED IT OFF AND THEN ON AGAIN, OR A 2ND OR 3RD USE CONCURRENTLY. I USED MY LITHIUM BATTERIES FROM THE BEGINNING AND THROUGHOUT THE ENTIRE FIRST MONTH WITHOUT ANY ISSUES IN THE ORIGINAL UNIT I PURCHASED. I REFRAINED FROM USING THE PRODUCT FOR ABOUT SIX DAYS, AND APPLIED CALAMINE LOTION TO HELP STOP THE ITCHING. I CAN'T FIND A PICTURE I THOUGHT I TOOK OF THE FIRST RASH. I INCLUDED A PICTURE OF THE SECOND RASH AND THE LITHIUM BATTERIES I USED. I WILL FOLLOW UP WITH ANOTHER PICTURE OF MY BACK SINCE IT IS FINE AND ALL HEALED NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506610 WITOUCH OVER-THE-COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR NUH HOLLYWOG, LLC 11.1510

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability WITOUCH