BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3070693 · Received April 15, 2013

    Report

    Report Number
    3007790958-2013-00059
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    March 12, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS SHE WAS LEANING AGAINST THE HEATING PAD WHICH IS ABUSE/MISUSE OF THE PRODUCT AND A DIRECT VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THE PAD HAS BEEN REQUESTED FROM THE CONSUMER TO DETERMINE IF THE INCIDENT AROSE FROM ABUSE/MISUSE OF THE PAD (I.E. BUNCHING/FOLDING/CRUSHING). A PREPAID LABEL WAS SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES SHE WAS USING THE HEATING PAD ON MEDIUM HEAT WHILE IN HER CHAIR AND WAS LEANING AGAINST THE HEATING PAD. TEN MINUTES LATER, SHE NOTICED THAT HER BACK WAS BURNED. SHE SOUGHT MEDICAL TREATMENT AND CLAIMS SHE WAS DIAGNOSED WITH 2ND AND 3RD DEGREE BURNS AND WAS INSTRUCTED TO TREAT WITH TYLENOL AND ALOE VERA LOTION. SHE CLAIMS THAT SHE DOES HAVE SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161855 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 753

    Patients

    Seq Age Sex Outcome Treatment
    1