BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 1969260 · Received January 15, 2011

    Report

    Report Number
    MW5019045
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    November 28, 2010
    Report Date
    January 15, 2011
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION = ON (B)(6) 2009, I PURCHASED A SUNBEAM CLASSIC HEATING PAD WITH 2-HOUR SHUT-OFF FEATURE, MODEL 832-915, DATE CODE (B)(4). THE PRODUCT WORKS WELL UNTIL THE AUTO SHUT-OFF FEATURE KICKS IN. WHEN THE AUTO SHUT-OFF FEATURE BEGINS, THE HEATING PAD COOLS DOWN BUT THE HEAT BUILDS UP IN THE CORD AND THE CONTROLS. THE HEAT BUILDS UP TO SUCH AN EXTENT THAT IT IS TOO HOT TO TOUCH THE CORD AND TOO HOT TO TOUCH THE CONTROLS AND THUS CANNOT TURN OFF THE UNIT. ON (B)(6) 2010, I HAD TO UNPLUG THE UNIT AT THE WALL BECAUSE OF THE INTENSE HEAT IN THE CORD AND THE CONTROLLER. I REPORTED MY CONCERNS TO SUNBEAM. THEY ASKED ME TO MAIL THE HEATING PAD TO THEM. I MAILED IT BACK TO THEM ON (B)(6) 2010 AND HAVE NOT HEARD ANYTHING SINCE FROM SUNBEAM. I AM REPORTING THIS POTENTIAL PRODUCT DEFECT BECAUSE, MY EXPERIENCE RAISES CONCERNS FOR THE RISK OF BURNS. THANK YOU. DIAGNOSIS OR REASON FOR USE: MUSCLE SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM SUNBEAM CLASSIC HEATING PAD MODEL 832-915 IRT 832-915

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability