BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 1821436 · Received August 26, 2010

    Report

    Report Number
    3004378258-2010-00033
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLDING IS ABUSE OF THE PRODUCT AND A DIRECT VIOLATION OF THE INSTRUCTIONS PROVIDED. PULLING THE CORD IS A DIRECT VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. SLEEPING WITH THE PAD IS A DIRECT VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. NO INJURIES WERE REPORTED WITH THIS INCIDENT. THIS INCIDENT IS DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HEATING PAD WAS LOCATED ON THE BED WHILE SHE WAS SLEEPING. CONSUMER AWOKE TO FIND THAT THE CORD HAD SCORCHED HER BEDDING IN A SMALL AREA. THERE WAS NOT A REPORT OF PERSONAL INJURY WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS 773-810

    Patients

    Seq Age Sex Outcome Treatment
    1