BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENS UNIT

    MDR report key: 2433139 · Received January 30, 2012

    Report

    Report Number
    MW5024020
    Event Type
    Other
    Date Received
    January 30, 2012
    Date of Event
    October 1, 2011
    Report Date
    January 30, 2012
    Manufacturer
    EMPI
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BUTTON ON THE BOX HAS A TENDENCY OF FALLING OUT WHICH RENDERS THE DEVICE INOPERABLE. WAS TOLD BY THE MANUFACTURER THAT THIS MODEL HAS A BAD ELECTRODE, WHICH IS A KNOWN DEFECT AND THEY ARE WORKING ON GETTING IT FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENS UNIT TENS UNIT GZJ EMPI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other