BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURELIEF WIRELESS 3-IN-1 PAIN RELIEF DEVICE

    MDR report key: 8394098 · Received March 5, 2019

    Report

    Report Number
    MW5084660
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    March 2, 2019
    Report Date
    March 2, 2019
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ATTACHED TENS OTC UNIT TO MY BACK AS USUAL AND POWERED IT ON. RECEIVED A PAINFUL, STUNNING SHOCK. UNIT WOULDN¿T POWER OFF AND I COULDN¿T REMOVE IT MYSELF DUE TO MUSCLE SPASMS, UNTIL THE DEVICE SPONTANEOUSLY CHANGED TO AN INTERMITTENT MODE. THE INTENSITY SETTING WAS AT 1, THE LOWEST LEVEL. DEVICE: ACCURELIEF ACRL-9100, COMPASS HEALTH BRANDS, CAREX HEALTH BRANDS LOT: SZ1510799. PAD EXP 31/05/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186263 ACCURELIEF WIRELESS 3-IN-1 PAIN RELIEF DEVICE STIMULATOR, MUSCLE, POWERED IPF COMPASS HEALTH BRANDS ACRL-9100 SZ1510799

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR