BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON SYNTHETIC SUTURE NEEDLE

    MDR report key: 12893 · Received March 9, 1994

    Report

    Report Number
    12893
    Event Type
    Other
    Date Received
    March 9, 1994
    Date of Event
    February 15, 1994
    Report Date
    March 9, 1994
    Manufacturer
    ETHICON, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH ITP UNDERGOING SURGERY, LAP SPLENECTOMY. NEEDLE BROKE, LEFT IN PT. NEEDLE VISIBLE ON X-RAY. NEEDLE WAS A GENERAL CLOSURE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SYNTHETIC SUTURE NEEDLE NEEDLE TAPER, CT-2 GAB ETHICON, INC. J-270 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other