BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 1193132 · Received October 7, 2008

    Report

    Report Number
    3005477599-2008-00044
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Report Date
    October 6, 2008
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PAD WAS SEVERELY BUNCHED/CRUSHED. BUNCHING/CRUSHING IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. NO INJURIES WERE REPORTED WITH THIS INCIDENT. THIS INCIDENT IS THE DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGES LYING ON A HEATING PAD IN BED FOR 30 MINUTES AND AWAKING TO FIND HER BEDDING SMOLDERING AND THE HEATING PAD MELTED. NO INJURIES WERE REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 532-612

    Patients

    Seq Age Sex Outcome Treatment
    1