BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 4912434 · Received July 10, 2015

    Report

    Report Number
    3007790958-2015-00104
    Event Type
    Injury
    Date Received
    July 10, 2015
    Report Date
    July 9, 2015
    Manufacturer
    SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO LEANING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNING PROVIDED. HEATING PAD IS BUNCHED/CRUSHED WHICH IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    DURING OUR FIRST CONTACT WITH CONSUMER HE ALLEGED THAT AFTER PROLONGED USE OF A HEATING PAD FOR BACK PAIN HE DEVELOPED A RASH ON HIS BACK. WHILE AT THE DOCTOR FOR ANOTHER ISSUE, HE WAS DIAGNOSED WITH ERYTHEMA AB IGNE (SKIN DISCOLORATION). CONSUMER ALSO WENT TO THE DOCTOR 3 MONTHS LATER FOR THE SAME AREA ON HIS BACK. THE DOCTOR FOUND A DARKENED AREA OF SKIN AND WAS ADVISED TO KEEP AN EYE ON IT FOR ANY CHANGES IN TEXTURE. SUBSEQUENTLY, CONSUMER INFORMED US THAT HE WAS ORIGINALLY DIAGNOSED WITH 2ND OR 3RD DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448946 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS 730-811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other