BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUNLAP

    MDR report key: 2062754 · Received April 4, 2011

    Report

    Report Number
    1314800-2011-00018
    Event Type
    Other
    Date Received
    April 4, 2011
    Date of Event
    February 14, 2009
    Report Date
    April 1, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HEATING PAD MALFUNCTIONED CAUSING SEVERE BURNS THAT HAVE LEFT SCARS. SHE CLAIMS THE HEATING PAD DID NOT SHUT OFF IN THE INTENDED TIME FRAME. BURNS OF THIS NATURE ARE DUE TO THE CONSUMER LAYING OR LEANING ON THE HEATING PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUNLAP HEATING PAD IRT KAZ INC R950WM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other