BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCA INTRODUCER

    MDR report key: 452843 · Received April 8, 2003

    Report

    Report Number
    1316297-2003-00001
    Event Type
    Other
    Date Received
    April 8, 2003
    Date of Event
    March 29, 2003
    Report Date
    April 7, 2003
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING LYSIS PROCEDURE. EPIDURAL INTRODUCER BECAME LODGED IN PT'S CAUDAL CANAL AND COULD NOT BE DISLODGED. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA INTRODUCER EPIDURAL NEEDLE BSP EPIMED INTERNATIONAL 135-4940 1240995

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention