BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOAMTEC NASAL SWAB

    MDR report key: 10307464 · Received July 21, 2020

    Report

    Report Number
    MW5095643
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    July 11, 2020
    Report Date
    July 17, 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

    SWAB TIP BROKE OFF IN NARES DURING LAB TESTING; RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766776 FOAMTEC NASAL SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0625202140

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention