BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3802914 · Received May 2, 2014

    Report

    Report Number
    3007790958-2014-00078
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    February 3, 2014
    Report Date
    May 2, 2014
    Manufacturer
    SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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). A PREPAID LABEL WAS SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT. CONSUMER HAS NOT RETURNED THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER CLAIMS SHE WAS USING HER HEATING PAD ON HER HIP AND AFTERWARDS NOTICED THAT SHE HAD TWO BLISTERS. SHE SOUGHT MEDICAL TREATMENT WHERE SHE CLAIMS SHE WAS DIAGNOSED WITH THIRD DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263776 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS 771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other