BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 2221472 · Received August 17, 2011

    Report

    Report Number
    3004378258-2011-00009
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    February 3, 2011
    Report Date
    August 16, 2011
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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. CONSUMER WAS SLEEPING WITH THE PAD WHICH IS ALSO ABUSE OF THE PRODUCT AND A VIOLATION OF THE WARNINGS AND INSTRUCTIONS PROVIDED. POWER CORD AT THE PAD ENTRANCE HAS BEEN SEVERELY PULLED WHICH IS ABUSE OF THE PRODUCT. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER ABUSE/MISUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER CLAIMS SHE WAS LAYING ON THE HEATING PAD FOR BACK, NECK AND SHOULDER PAIN. THE HEATING PAD WAS UNDER HER HEAD WHEN SHE AWOKE TO FIND IT EXTREMELY HOT AND NOTICED IT WAS SMOLDERING AND DAMAGED HER PILLOW. SHE ALSO SUSTAINED A BURN TO HER BACK WHICH REQUIRED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 733-810

    Patients

    Seq Age Sex Outcome Treatment
    1