BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 2221473 · Received August 17, 2011

    Report

    Report Number
    3004378258-2011-00010
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CRUSHING THE PAD IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE WARNINGS AND INSTRUCTIONS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER ABUSE / MISUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER SENT THE HEATING PAD TO UNDERWRITERS LABORATORIES W/O ANY COMPLAINT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 771-810

    Patients

    Seq Age Sex Outcome Treatment
    1