BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALGESIC INTENSITY 10

    MDR report key: 5001401 · Received July 15, 2015

    Report

    Report Number
    5001401
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 15, 2015
    Manufacturer
    ANALGISIC
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PLACED TENS UNIT ON PATIENT IN 4 LOCATIONS. THREE ON ARM, 1 ON UPPER TRAP. TENS UNIT INCREASED INTENSITY AND WOULD NOT TURN OFF. BATTERIES HAD TO BE TAKEN OUT TO TURN OFF. PATIENT STATES THAT AFTER TREATMENT THAT THE ELECTRODES ON RIGHT TRAP, INNER RIGHT BICEP, AND TRICEPS BURNT PATIENT AND 2ND DEGREE BURN. PT EXPLAINS THAT SINCE INCIDENT THAT HE HAS NUMBNESS FROM FOREARM DOWN AND GRIP STRENGTH HAS DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461280 ANALGESIC INTENSITY 10 TENS UNIT INTENSITY 10 GZJ ANALGISIC 5130121265

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other