BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITOUCH PRO

    MDR report key: 8816732 · Received July 23, 2019

    Report

    Report Number
    3008585473-2019-00004
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 10, 2018
    Report Date
    July 23, 2019
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    NUH
    PMA / PMN Number
    K171599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND ON THE INTERNET DURING POSTMARKET SURVEILLANCE OF ANONYMOUS CUSTOMER REVIEWS WITH LIMITED INFORMATION PROVIDED FOR AN INVESTIGATION. THE CERTIFICATES OF COMPLIANCE FOR THE GEL PADS WERE REVIEWED BY THE QMS MANAGEMENT REPRESENTATIVE FOR A PERIOD OF TWO YEARS PRIOR TO THE DATE OF THE ANONYMOUS CUSTOMER REVIEW DATE SHOWN ON THE INTERNET. THIS REVIEW SHOWED THE GEL PADS WERE SUPPLIED TO SPECIFICATION.

    Description of Event or Problem · 1

    THESE PADS ARE APPARENTLY NOT LATEX FREE. AFTER SEVERAL USES MY BACK BECAME RED AND IRRITATED WHERE THE PADS HAD BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609859 WITOUCH PRO TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR NUH HOLLYWOG, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability