BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESWAB

    MDR report key: 10078432 · Received May 20, 2020

    Report

    Report Number
    MW5094613
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 18, 2020
    Manufacturer
    COPAN ITALIA
    Product Code
    JTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SEVERE PROLONGED BLEEDING GREATER THAN 1 HOUR FROM COVID 19 TESTING USING COPAN ESWAB 480C WHITE CAP VIA NASOPHARYNGEAL ROUTE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537371 ESWAB SYSTEM, TRANSPORT, AEROBIC JTW COPAN ITALIA 480C

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R