BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOQSWABS COPAN FLOCKED SWABS

    MDR report key: 10717587 · Received October 21, 2020

    Report

    Report Number
    MW5097371
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 20, 2020
    Manufacturer
    COPAN DIAGNOSTICS INC
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COVID SWAB TEST PERFORMED. PT EXPERIENCED HEADACHE, TRACE BLEEDING AND TEARING OF THE EYES. PT ALSO COMPLAINED THAT SHE "FELT SOMETHING IN HER NOSE". LATER THAT DAY PT HAD RINGING IN HER EARS. PT ALSO NOTED THAT AFTER 4 DAYS FOLLOWING THE TEST HER LEFT NOSTRIL "STILL HURTS". THE FLOQSWABS COPAN FLOCKED SWABS WAS USED. LOT # 192020, EXP 05/2024. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174041 FLOQSWABS COPAN FLOCKED SWABS APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN DIAGNOSTICS INC 503CS01.BD10001L20 1920240

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other