BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIDURAL CATHETER

    MDR report key: 16232 · Received June 14, 1994

    Report

    Report Number
    16232
    Event Type
    Other
    Date Received
    June 14, 1994
    Date of Event
    June 8, 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 CAME TO PAIN CLINIC WITH TENDERNESS TO ENTIRE RIGHT FLANK. AREA SURROUNDING THE CATHETER EXIT SITE VERY HOT, HARD TO TOUCH AND TENDER. PT WAS TAKEN TO SURGERY FOR EMERGENCY REMOVAL OF A PORTION OF THE EPIDURAL CTHETER WITH IRRIGATION. PT ADMITTED TO ICU AND SCHEDULED FOR INSERTION OF EPIDURAL CATHETER 5 DAYS LATER. ORIGINAL CATHETER HAD BEEN INSERTED 10/21/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER Implant EPIDURAL CATHETER BSO BARD ACCESS SYSTEMS, INC. 0602902 36FD4329

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other