BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULATED HOT PACK, LARGE, 6X9IN

    MDR report key: 17580548 · Received August 18, 2023

    Report

    Report Number
    1423537-2023-00982
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 10, 2023
    Manufacturer
    RAPID AID CORP
    Product Code
    IMD
    UDI-DI
    00630140039839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER STATED PATIENT CARE TECH WENT TO SQUEEZE HOT PACK TO ACTIVATE FOR PATIENT. HOT PACK BURST, COVERING EMPLOYEE EYES IN THE FLUID FROM THE PACK. THE HOT PACK WAS DISCARDED. NO ADVERSE INJURY TO EMPLOYEE AND NO TREATMENT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094966 INSULATED HOT PACK, LARGE, 6X9IN PACK, HOT OR COLD, DISPOSABLE IMD RAPID AID CORP 30104 VN22361-78 00630140039839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown