BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESWAB

    MDR report key: 17584014 · Received August 21, 2023

    Report

    Report Number
    17584014
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 16, 2023
    Report Date
    July 19, 2023
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TESTING WAS UNABLE TO BE COMPLETED DUE TO FAULTY COLLECTION DEVICE. NO FLUID WAS IN THE COLLECTION VIAL THEREFORE TESTING WAS UNABLE TO BE PERFORMED. PATIENT HAD TO COME BACK FOR ANOTHER SWAB COLLECTION. A NEW LAB ORDER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490716 ESWAB SYSTEM, TRANSPORT, AEROBIC JTW COPAN ITALIA SPA N30173600

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA Female