BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOQSWABS

    MDR report key: 10205871 · Received June 26, 2020

    Report

    Report Number
    MW5095248
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 24, 2020
    Manufacturer
    COPAN FLOCK TECHNOLOGIES S.R.L. / COPAN DIAGNOSTICS, INC.
    Product Code
    KXG
    UDI-DI
    50382902202528
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD ADULT FEMALE CAME TO ER FOR ROUTINE SARS-COV-2 TEST SPECIMEN COLLECTION ("DRIVE-THROUGH" COLLECTION). SWAB USED WAS "FLOQSWABS FLEXIBLE, STERILE, WRAPPED, MOLDED BP 100MM) REF # 220252, BATCH 098L18, LOT 180824252, EXPIRATION 5/31/2021. SWAB ENTERED RIGHT NOSTRIL AND BROKE OFF AT JUNCTION OF SLENDER SHAFT AND THICKER SHAFT HANDLE. PER THE COLLECTING NURSE, THE PATIENT DID NOT STRUGGLE OR MOVE ABOUT DURING COLLECTION. IN ORDER TO REMOVE THE SWAB END, THE PATIENT WAS TAKEN TO THE OPERATING ROOM. ACCORDING TO THE OPERATIVE REPORT, AN ENDOSCOPE WAS UTILIZED. DUE TO THE DIFFICULTY OF REMOVAL AND EXTREME DISCOMFORT, PATIENT CONSENTED TO SEDATION. IT WAS NOTED NO BLEEDING OR COUGHING/SIGNS OF ASPIRATION WERE SEEN. OCCURRENCE WAS DURING SPECIMEN COLLECTION FOR SARS-COV-2 PCR TESTING TO BE PERFORMED AT LOCAL COUNTY HEALTH LABORATORY (B)(6). DUE TO NEED FOR A PROCEDURE TO REMOVE THE SWAB, A RAPID MOLECULAR METHOD (ABBOTT ID NOW) WAS USED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667895 FLOQSWABS APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN FLOCK TECHNOLOGIES S.R.L. / COPAN DIAGNOSTICS, INC. FLOQSWABS, FLEXIBLE 180824252 50382902202528

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention