BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH

    MDR report key: 5549382 · Received April 5, 2016

    Report

    Report Number
    3008585473-2016-00611
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    November 30, 2015
    Report Date
    March 7, 2016
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    PMA / PMN Number
    K120500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRE-PAID POSTAGE PACKAGE HAS BEEN PROVIDED TO THE COMPLAINANT TO RETURN THE DEVICE FOR EVALUATION. AFTER RECEIPT OF THE PRE-PAID RETURN PACKAGE, THE COMPLAINANT DECIDED NOT TO RETURN THE DEVICE. THE QMS REPRESENTATIVE REVIEWED THE ASSEMBLY PROCESS INCLUDING THE DEVICE HISTORY RECORD AND NO ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 1

    I BOUGHT THE PRODUCT AND USED IT WITH THE ORIGINAL GEL-PADS WITH NO PROBLEMS. WHEN THE ORIGINAL GEL-PADS WERE USED UP, I PURCHASED REPLACEMENT GEL-PADS ONLINE. APPROXIMATELY FOUR MONTHS AGO WHEN I BEGAN USING THE REPLACEMENT GEL-PADS, I NOTICED A RASH BEGINNING IN THE AREA OF MY LOWER BACK WHERE THE PRODUCT AND REPLACEMENT GEL-PADS WERE USED. OVER TIME THE RASH BEGAN SPREADING ACROSS MY BACK AND HAS NOW SPREAD UP TO MY NECK, AND SPREAD DOWN TO THE BUTT AREA. MY PHYSICIAN DIAGNOSED THE RASH TO BE STAPH INFECTION BY COMPARING THE RASH TO PHOTOS OF RASHES IN A BOOK. I HAVE NEVER HAD STAPH INFECTION BEFORE IN MY LIFE. FOUR DAYS AGO, MY PHYSICIAN PRESCRIBED ANTIBIOTICS FOR ME TO TAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204074 WITOUCH STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH HOLLYWOG, LLC 11.1510

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability