BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS HOT PACK, MEDIUM, 6X6.5

    MDR report key: 17748768 · Received September 14, 2023

    Report

    Report Number
    1423537-2023-00989
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 12, 2023
    Manufacturer
    RAPID AID CORP
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    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 STATED WE JUST RECEIVED A PRODUCT CONCERN FORM FROM THE GOOD SAMARITAN LAB FOR A MEDIUM HOT PACK THAT EXPLODED/LEAKED. THERE WAS NO INJURY TO PATIENT OR EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183485 NOVAPLUS HOT PACK, MEDIUM, 6X6.5 PACK, HOT OR COLD, DISPOSABLE IMD RAPID AID CORP V11450-040B VN23132-2324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown