BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3854891 · Received May 27, 2014

    Report

    Report Number
    3007790958-2014-00094
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 23, 2014
    Manufacturer
    SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. 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).

    Description of Event or Problem · 1

    CONSUMER CLAIMS SHE WAS USING A HEATING PAD AND IT DID NOT TURN OFF. SHE IS ALLEGING IT BURNED HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311866 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other