BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON CHROMIC GUT 1 CT NEEDLE

    MDR report key: 511417 · Received February 13, 2004

    Report

    Report Number
    511417
    Event Type
    Other
    Date Received
    February 13, 2004
    Date of Event
    October 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    ETHICON INC
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING C-SECTION PROCEDURE DR NOTICED THAT TIP WAS BLUNT, UPON INSPECTION BY A SURGEON THE TIP WAS IDENTIFIED AS BEING BROKEN. NEEDLE TIP NOT FOUND IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON CHROMIC GUT 1 CT NEEDLE SUTURE GAB ETHICON INC 915 SHM567

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other HOLDER.| SUTURE HAD BEEN PREVIOUSLY CLAMPED INTO A NEEDLE