BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCA EPIDURAL INTRODUCER

    MDR report key: 671339 · Received January 31, 2006

    Report

    Report Number
    1316297-2006-00001
    Event Type
    Other
    Date Received
    January 31, 2006
    Date of Event
    January 26, 2006
    Report Date
    January 29, 2006
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED THAT THE EXPERIENCED GREAT DIFFICULTY IN POSITIONING SCA INTRO-DUCER IN PT DUE TO EXCESSIVE SCAR TISSUE. WHEN INTRODUCER WAS INSERTED AND PROCEEDURE COMPLETED, THE DR FORCIBLY REMOVED INTRODUCER WHICH CAUSED IT TO STRETCH AND EVENTUALLY BREAK LEAVING A 1-1/2 INCH SECTION IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA EPIDURAL INTRODUCER EPIDURAL INTRODUCER BSO EPIMED INTERNATIONAL 135-4940 12401307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN