BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHEAT HEAT PACK

    MDR report key: 548283 · Received September 7, 2004

    Report

    Report Number
    MW1033515
    Event Type
    Injury
    Date Received
    September 7, 2004
    Date of Event
    July 6, 2004
    Report Date
    August 24, 2004
    Manufacturer
    MEDIHEAT
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BURN - 2ND-3RD DEGREE. ITEM REACHES A TEMP OF 130-140 DEGREES F AND LASTS UP TO 18 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIHEAT HEAT PACK HEAT PACK IMD MEDIHEAT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization