BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUPEN EPIDURAL CATHETER

    MDR report key: 16230 · Received June 14, 1994

    Report

    Report Number
    16230
    Event Type
    Other
    Date Received
    June 14, 1994
    Date of Event
    June 11, 1994
    Report Date
    June 14, 1994
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    BSO
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE EMERGENCY ROOM WITH BRUISES, REDNESS, TENDERNESS, EDEMA, AND OOZING ECCHYMOTIC CATHETER SITE TO THE RIGHT FLANK AND BACK. PT WAS TAKEN TO SURGERY FOR EMERGENCY REMOVAL OF THE CATHETER WHICH HAD BEEN IMPLANTED 11/23/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUPEN EPIDURAL CATHETER Implant EPIDURAL CATHETER BSO BARD ACCESS SYSTEMS, INC. 0602902 364D1871

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other