BEUDAMED
    FDA Adverse Event Other Summary report: N

    HP 218 HEATING PAD

    MDR report key: 1483975 · Received September 22, 2009

    Report

    Report Number
    1314800-2009-00023
    Event Type
    Other
    Date Received
    September 22, 2009
    Date of Event
    May 18, 2009
    Report Date
    September 19, 2009
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S ((B) (6)) ATTORNEY SENT A NOTICE TO KAZ THAT WAS RECEIVED ON 08/19/2009, STATING THAT THE MODEL HP 218 HEATING PAD CAUSED SEVERE BURNS TO THE CONSUMER'S LOWER LEFT LEG. THE NOTICE ALSO STATED THAT THE CONSUMER USED THE PAD SEVERAL TIMES BEFORE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HP 218 HEATING PAD HEATING PAD IRT KAZ, INC. HP 218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other