BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1952934 · Received January 3, 2011

    Report

    Report Number
    1314800-2010-00050
    Event Type
    Other
    Date Received
    January 3, 2011
    Date of Event
    November 19, 2010
    Report Date
    December 9, 2010
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS FROM USING THE HEATING PAD. THE INCIDENT WAS REPORTED DIRECTLY TO THE RETAILER AND THE EXTENT OF THE INJURIES IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ INC HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other