BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAR HYPOTHERMIA PREVENTION AND MANAGEMENT KIT (HPMK)

    MDR report key: 10059593 · Received May 14, 2020

    Report

    Report Number
    3005034064-2020-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Report Date
    July 8, 2020
    Manufacturer
    NORTH AMERICAN RESCUE, LLC
    Product Code
    IMD
    PMA / PMN Number
    K042145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CALLED IN AND STATED THE HPMK IS CAUSING BURNS AND THAT IN ONE INCIDENT THE CASUALTY REQUIRED A SKIN GRAFT. HPMK IS NAR ITEM NUMBER 80-0027.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN AND STATED THE HPMK IS CAUSING BURNS AND THAT IN ONE INCIDENT THE CASUALTY REQUIRED A SKIN GRAFT. HPMK IS NAR ITEM NUMBER 80-0027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518330 NAR HYPOTHERMIA PREVENTION AND MANAGEMENT KIT (HPMK) HYPOTHERMIA PREVENTION DISPOSABLE HOT PACK IMD NORTH AMERICAN RESCUE, LLC 80-0027 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1