BEUDAMED
    FDA Adverse Event Other Summary report: N

    RACZ TUN-L-XL

    MDR report key: 99416 · Received June 18, 1997

    Report

    Report Number
    1316297-1997-00003
    Event Type
    Other
    Date Received
    June 18, 1997
    Date of Event
    June 3, 1997
    Report Date
    June 17, 1997
    Manufacturer
    EPIMED INTL., INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DR WAS ATTEMPTING TO WITHDRAW THE CATHETER DUE TO POOR PLACEMENT. WHILE RETRACTING THE CATHETER IT CAUGHT AND WAS SHEARED OFF. A GENERAL SURGEON WAS BROUGHT IN TO REMOVE SHEARED PIECE. THIS WAS LOCATED AND REMOVED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACZ TUN-L-XL EPIDURAL CATHETER BSO EPIMED INTL., INC. 155-2540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention EPIDURAL NEEDLE