BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITOUCH

    MDR report key: 6026815 · Received October 13, 2016

    Report

    Report Number
    3008585473-2016-00620
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 13, 2016
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    UDI-DI
    00853096004014
    PMA / PMN Number
    K120500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW SHOWS THE DEVICE PERFORMED AS INTENDED WHEN IT WAS MANUFACTURED. DURING EVALUATION THE DEVICE AND DEVICE REMOTE WERE FOUND IN POOR CONDITION. THE DEVICE AND DEVICE REMOTE CONTROL WERE ABLE TO POWER ON. THE DEVICE TREATMENT WAS ABLE TO FUNCTION TO SPECIFICATION, FREQUENCIES WERE TO SPECIFICATION. THE DEVICE LABELING WAS REVIEWED AND FOUND TO BE SUITABLE AND ADEQUATE FOR THE DEVICE TO PERFORM ITS INTENDED USE. THE DEVICE PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER HAS SPINAL STENOSIS AND HAS BEEN WEARING THE DEVICE FOR TWO WEEKS. THERE WERE NO PROBLEMS UNTIL (B)(6) 2016. SHE WAS WEARING THE UNIT ALL DAY AND IT HAD TURNED ITSELF OFF. CUSTOMER SAID SHE "GOT IN THE CAR TO GO SOMEWHERE AND ALL OF A SUDDEN IT LET OUT A CHARGE THAT TIGHTENED EVERY MUSCLE IN MY BODY AND CAUSED ME TO YELL OUT LOUD." SHE HAD HER REMOTE CONTROL AROUND HER NECK AND WAS ABLE TO DECREASE THE INTENSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679980 WITOUCH OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR NUH HOLLYWOG, LLC 11.1510 00853096004014

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability