BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNBEAM

    MDR report key: 3040978 · Received June 13, 2006

    Report

    Report Number
    3005477599-2006-00020
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Report Date
    June 13, 2006
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2006, THIS PRODUCT WAS TESTED BY VISUAL INSPECTION. ONLY THE CONTROLLER WAS RETURNED BY THE COMPLAINANT. IT WAS DETERMINED THAT THERE WAS A WIRE BREAK ON BOTH WIRES GOING INTO THE CONTROL DUE TO ABUSE, AS THE POWER CORD WAS SEVERELY PULLED AT AN ANGLE. THE INSULATION WAS OFF OF BOTH WIRES BUT ALL OF THE WIRES WERE NOT BROKEN COMPLETELY INTO ALLOWING THE PAD TO CONTINUE TO FUNCTION. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE / ABUSE OF THE PRODUCT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGES STRESS BREAK TO CORD OF HEATING PAD. NO INJURY OR PROPERTY DAMAGED REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 809-015

    Patients

    Seq Age Sex Outcome Treatment
    1