BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUN-L-XLT CATHETER

    MDR report key: 227568 · Received June 14, 1999

    Report

    Report Number
    MW1016520
    Event Type
    Injury
    Date Received
    June 14, 1999
    Date of Event
    May 24, 1999
    Report Date
    June 14, 1999
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EPIDUROLYSIS PROCEDURE RACZ CATHETER SHEARED OFF LEAVING A 10CM PORTION IN THE MUSCLE OF THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-XLT CATHETER Implant * BSO EPIMED INTERNATIONAL, INC. * 811555

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention