BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULATED HOT PACK, LARGE, 6X9IN

    MDR report key: 17716523 · Received September 8, 2023

    Report

    Report Number
    1423537-2023-00987
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    July 13, 2023
    Report Date
    October 12, 2023
    Manufacturer
    RAPID AID CORP
    Product Code
    IMD
    UDI-DI
    00630140039839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS FILED IN ERROR. CARDINAL HEALTH IS NOT THE LEGAL MANUFACTURER OF THIS DEVICE. THE LEGAL MANUFACTURER IS RAPID AID IN MISSISSAUGA, ONTARIO CANADA. THE MANUFACTURER HAS BEEN NOTIFIED OF THE EVENT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED HEAT PACK WAS PLACED DIRECTLY ON SKIN OF LOWER BACK AND CAUSED 2ND DEGREE BURN. NO MEDICATION WAS GIVEN AS PATIENT REPORTED THE ISSUE TO THE STAFF AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502543 INSULATED HOT PACK, LARGE, 6X9IN PACK, HOT OR COLD, DISPOSABLE IMD RAPID AID CORP 30104 VN23045-2021 00630140039839

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male