BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3212755 · Received July 1, 2013

    Report

    Report Number
    3007790958-2013-00097
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 13, 2011
    Report Date
    June 28, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATES SHE WAS LAYING ON THE HEATING PAD FOR BACK PAIN AND AFTER 45 MINUTES, SHE SUSTAINED A BURN TO HER BUTTOCKS. MEDICAL RECORDS INDICATE SHE WAS TAKING PAIN MEDICATION FOR HER CHRONIC BACK PAIN AND FELL ASLEEP WHILE USING THE HEATING PAD, WHICH IS A VIOLATION OF THE WARNINGS AND INSTRUCTIONS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    A LAWSUIT WAS FILED ON (B)(6) 2013. THE PLAINTIFF IS ALLEGING THAT SHE WAS USING THE HEATING PAD ON HER BACK AND SUSTAINED A 2ND DEGREE BURN THAT REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297838 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 536-912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other