BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE CLEAN WIPE FOAM SWAB

    MDR report key: 11601761 · Received March 31, 2021

    Report

    Report Number
    MW5100441
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 29, 2021
    Manufacturer
    FOAMTEC INTERNATIONAL CO., LTD.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN SWABBED PT'S LEFT NARE FOR PRE OP COVID SWAB AND PT MOVED. WHEN RN PULLED SWAB OUT, COTTON TIP ON SWAB WAS MISSING. PRESUMED IN PT'S NARE OR NASOPHARYNX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497559 STERILE CLEAN WIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0813202411

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR