BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREX

    MDR report key: 11601592 · Received April 1, 2021

    Report

    Report Number
    3012316249-2021-00015
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PRELIMINARY INVESTIGATION INDICATES THAT THE FIRE MAY HAVE BEEN CAUSED BY A "BED BUDDY HEAT WRAP". CLAIM FOR DAMAGES. RECEIVED NOTICE OF A FIRE LOSS ON MARCH 1, 2021 CAUSING DAMAGE TO THE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501413 CAREX BED BUDDY HEAT WRAP IME COMPASS HEALTH BRANDS

    Patients

    Seq Age Sex Outcome Treatment
    1