BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 3040609 · Received March 13, 2013

    Report

    Report Number
    3007790958-2013-00023
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAN PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (I.E. BUNCHING/FOLDING/CRUSHING). A PREPAID LABEL WAS SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES SHE USED THE HEATING PAD FOR ABOUT 20 MINUTES AND SHUT IT OFF AND LEFT IT ON HER COUCH. WHEN SHE RETURNED TO THE ROOM, THE WHOLE ROOM WAS FILED WITH SMOKE AND SHE THREW THE HEATING PAD OUTSIDE. HER COUCH SUSTAINED A BURN MARK THE SIZE OF A SOFTBALL. NO INJURIES WERE REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106186 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAN PRODUCTS 2011-912

    Patients

    Seq Age Sex Outcome Treatment
    1