BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROGENT/SWAB COMBO

    MDR report key: 345678 · Received August 1, 2001

    Report

    Report Number
    1924669-2001-00001
    Event Type
    Injury
    Date Received
    August 1, 2001
    Date of Event
    July 25, 2001
    Report Date
    July 31, 2001
    Manufacturer
    REMEL INC.
    Product Code
    LIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH COMPLAINT OF DRAINAGE FROM PENIS. DEVICE INSERTED INTO URETHRA TO OBTAIN SPECIMEN. WHEN DEVICE WAS REMOVED COTTON TIP WAS RETAINED IN URETHRA. PT'S URINE WAS SCREENED AND COLLECTED WITH NO RETURN OF THE COTTON VISUALIZED. PT UNDERWENT URETHROSCOPY AND CYSTOSCOPY WHICH WERE UNSUCCESSFUL IN LOCATING THE COTTON TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34584 MICROGENT/SWAB COMBO SINGLE USE DISPOSABLE SAMPLE COLLECTION LIO REMEL INC. * 042337

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization