BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH

    MDR report key: 6704027 · Received July 11, 2017

    Report

    Report Number
    3008585473-2017-00010
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    May 6, 2017
    Report Date
    June 7, 2017
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    UDI-DI
    00853096004014
    PMA / PMN Number
    K120500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW SHOWS THE DEVICE PERFORMED AS INTENDED WHEN IT WAS MANUFACTURED. THE TENS DEVICE AND HANDHELD REMOTE CONTROL WERE ABLE TO POWER ON. THE DEVICE OUTPUT TREATMENT FREQUENCIES WERE TO SPECIFICATION, HOWEVER, THE WAVEFORM WAS NOT TO SPECIFICATION. THE DEVICE IS WILL BE EVALUATED BY THE DESIGN ENGINEERS FOR ROOT CAUSE OF THE WAVEFORM NOT PERFORMING TO SPECIFICATION. THE DEVICE LABELING WAS REVIEWED AND FOUND TO BE SUITABLE AND ADEQUATE FOR THE DEVICE TO PERFORM ITS INTENDED USE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT WHEN SHE PRESSED THE POWER BUTTON ON THE REMOTE CONTROL TO START THE TREATMENT, THE DEVICE GAVE HER A "JOLT" AND THEN STOPPED WORKING ALTOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482667 WITOUCH OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR NUH HOLLYWOG, LLC 11.1510 00853096004014

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability