BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREVI-XL

    MDR report key: 360028 · Received November 1, 2001

    Report

    Report Number
    1316297-2001-00001
    Event Type
    Other
    Date Received
    November 1, 2001
    Date of Event
    October 19, 2001
    Report Date
    November 1, 2001
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR. PERFORMED CAUDAL PROCEDURE. WHEN PROCEDURE WAS COMPLETED AND CATHETER WAS REMOVED, A 2-2.5 INCH SECTION OF CATHETER REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48955 BREVI-XL EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. NA 1140652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other RK NEEDLE, 16 GA.