BEUDAMED
    FDA Adverse Event Summary report: N

    BACK SUPPORT BELT

    MDR report key: 3020651 · Received March 22, 2013

    Report

    Report Number
    MW5029430
    Date Received
    March 22, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    TECTRON
    Product Code
    IQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED BACK SUPPORT BELT FROM CONSUMER SHOPPING THROUGH (B)(6). OPENED THE PACKAGE OF THE FIRST BACK SUPPORT BELT, AN ODOR EMITTED FROM IT AND A WATER SUBSTANCE WAS LEAKING FROM IT. CONTACTED THE SELLER AND THEY AGREED TO SEND HIM ANOTHER ONE. PT RECEIVED THE SECOND BACK SUPPORT BELT ON (B)(6) 2013 AND A NOTICEABLE ODOR EMITTED FROM IT AS WELL. THE TOXIC FUME FILLED THE ROOM WHICH MADE PT NAUSEOUS. THERE IS A LABEL WARNING ON THE DEVICE INDICATING IT CAN CAUSE CANCER, BIRTH DEFECTS AND REPRODUCTIVE HARM. PT IS CONCERNED THAT THE DEVICE IS TOXIC WHICH CAN CAUSE SERIOUS PROBLEMS TO CONSUMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119508 BACK SUPPORT BELT BACK SUPPORT BELT IQE TECTRON
    119509 BACK SUPPORT BELT BACK SUPPORT BELT IQE TECTRON

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other