BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 TESTING SWABS

    MDR report key: 10592590 · Received September 25, 2020

    Report

    Report Number
    MW5096886
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 24, 2020
    Manufacturer
    FOAMTEC INTERNATIONAL CO., LTD.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOAM TIP OF TWO COVID SWABS BROKE OFF WERE RETAINED IN PATIENT WHEN SWABBING NARES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052823 COVID-19 TESTING SWABS APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 625202140

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR