BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1221163 · Received October 21, 2008

    Report

    Report Number
    1221163
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    DURING A C-SECTION THE TIP OF A NEEDLE BROKE OFF INTO THE PATIENT'S ABDOMEN. THE TIP WAS NOT RECOVERED. THE TIP OF THE NEEDLE BROKE WHILE SUTURING THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * NEEDLE, SUTURE GAB ETHICON, INC. * AJM846

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR NO OTHER THERAPIES| NO OTHER THERAPIES