BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREVI-XL

    MDR report key: 372843 · Received January 22, 2002

    Report

    Report Number
    1316297-2002-00001
    Event Type
    Other
    Date Received
    January 22, 2002
    Date of Event
    January 14, 2002
    Report Date
    January 18, 2002
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR. HAS PERFORMED LYSIS, WHEN PROCEDURE WAS COMPLETED AND HE REMOVED THE CATHETER, HE DISCOVERED THAT THE CATHETER HAD SHEARED AND THAT A SECTION OF THE CATHETER'S "FEP" COATING HAD REMAINED IN THE PT.

    Devices

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

    Patients

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