BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2061070 · Received April 4, 2011

    Report

    Report Number
    1314800-2009-00054
    Event Type
    Other
    Date Received
    April 4, 2011
    Date of Event
    August 20, 2009
    Report Date
    April 1, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED HAVING RECEIVED BURNS FROM USING THE HEATING PAD. SHE FELL ASLEEP ON THE HEATING PAD WHILE TAKING NARCOTICS WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other