BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 1160743 · Received September 8, 2008

    Report

    Report Number
    3005477599-2008-00034
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    September 7, 2008
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. COMPLAINANT ALSO USED THE PRODUCT WHILE SLEEPING, WHICH IS ANOTHER ABUSE OF THE PRODUCT, AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. NO INJURIES WERE REPORTED WITH THIS INCIDENT. THIS INCIDENT IS DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGES USING A HEATING PAD IN BED FOR 30 MINS AND THEN TURNING THE UNIT OFF. TWO HOURS LATER, SHE AWOKE TO A SMOKE FILLED ROOM AND FOUND THE HEATING PAD HAD BURNED HER BEDDING. 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 532-616

    Patients

    Seq Age Sex Outcome Treatment
    1