BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 1160744 · Received September 8, 2008

    Report

    Report Number
    3005477599-2008-00035
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    January 18, 2008
    Report Date
    September 8, 2008
    Manufacturer
    JARDEN CONSUMER SOLUTION, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONSUMER MODIFIED THE PRODUCT BY USING AN IMPROPER CONTROLLER, AND NOT THE ONE PROVIDED WITH THE PAD, WHICH IS ABUSE OF THE PRODUCT. NO INJURIES WERE REPORTED WITH THIS INCIDENT. THIS INCIDENT IS DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGES A HEATING PAD SMOKED AND MELTED, BURNING A HOLE IN THE PAD. NO PROPERTY DAMAGE OR INJURY WAS REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTION, DBA SUNBEAM PRODUCTS 538-5

    Patients

    Seq Age Sex Outcome Treatment
    1