BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 3043041 · Received March 15, 2013

    Report

    Report Number
    3007790958-2013-00032
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD HAS BEEN REQUESTED FROM THE CONSUMER TO DETERMINE IF THE INCIDENT AROSE FROM ABUSE/MISUSE OF THE PAD. A PREPAID LABEL TO THE CONSUMER FOR RETURN OF THE PRODUCT, BUT CONSUMER HAS NOT RETURNED THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES HER HEATING PAD WAS SO HOT INSIDE THAT IT WAS SMOULDERING. NO INJURIES OR DAMAGES WERE REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110436 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 832

    Patients

    Seq Age Sex Outcome Treatment
    1