BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3894063 · Received June 13, 2014

    Report

    Report Number
    3007790958-2014-00099
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. WE ATTEMPTED ON NUMBEROUS OCCASIONS TO CONTACT THIS CONSUMER, BUT HAVE NOT HAD ANY RESPONSE. THE PAD HAS BEEN REQUESTED FROM THE CONSUMER TO DETERMINE IF THE INCIDENT AROSE FROM AROUSE/MISUSE OF THE PAD (I.E. BUNCHING/FOLDING/CRUSHING).

    Description of Event or Problem · 1

    A RETAILER CONTACTED US REGARDING A CONSUMER'S ALLEGATION THAT A HEATING PAD CAUSED A SECOND DEGREE BURN DUE TO THE HEATING PAD SHORTING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351304 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other