BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESWAB

    MDR report key: 6724331 · Received July 19, 2017

    Report

    Report Number
    6724331
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 8, 2017
    Report Date
    June 12, 2017
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    JTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ESWAB WAS LAYING ON THE COUNTER, CLEAR BACK SIDE FACING UP. A BUG WAS NOTICED TO BE FLOATING IN THE FLUID. PACKAGE UNOPENED. MANUFACTURER RESPONSE FOR ESWAB COLLECTION AND PRESERVATION OF AEROBIC, ANAEROBIC &, ESWAB (PER SITE REPORTER). THE MANUFACTURER TOOK MY PHONE CALL AND SAID THAT THEY WOULD BE SENDING ME INSTRUCTIONS TO START THE RETURN CREDIT PROCESS AND QUALITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507074 ESWAB SYSTEM, TRANSPORT, AEROBIC JTW COPAN DIAGNOSTICS, INC. H295FMB LQ ANUES 9M2G

    Patients

    Seq Age Sex Outcome Treatment
    1