BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEFBAND 2.0

    MDR report key: 16708355 · Received April 10, 2023

    Report

    Report Number
    MW5116492
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 7, 2021
    Report Date
    April 6, 2023
    Manufacturer
    RELIEFBAND TECHNOLOGIES LLC.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CHARGER FOR THE RELEIFBAND WRIST DEVICE FOR MOTION SICKNESS WAS PLACED NEXT TO A METALLIC WATCH BAND ON MY APPLE WATCH. THEY WERE PLACE NEXT TO EACH OTHER ON THE COUNTER. THE EXPOSED ELECTRICAL CONDUCTS ON THE CHARGER (THE TIP WITH THE GOLD COLOR THAT YOU USE TO CHARGE THE BAND) CONTACTED THE METALLIC BAND AND CAUSE SMOKE AND BURN THROUGH THE METAL. IT CAUSED A SMALL FIRE INCIDENT THAT BURNT THE METALLIC WATCH BAND. LUCKILY I WOKE UP IN THE MIDDLE OF THE NIGHT AFTER SMELLING THE SMOKE AND REMOVING THE ITEMS. NO INJURIES. THE DESIGN OF THE CHARGER SHOULD BE IMPROVED SO THE ELECTRICAL COMPONENTS ARE NOT EXPOSED TO PREVENT CONTACT WITH NEARBY MATERIALS AND CAUSING A FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754024 RELIEFBAND 2.0 STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF GZJ RELIEFBAND TECHNOLOGIES LLC. 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female