BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS

    MDR report key: 3080005 · Received April 3, 2013

    Report

    Report Number
    3080005
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLOSING LAYERS WHERE A COLOSTOMY HAD BEEN WHEN THE NEEDLE BROKE OFF IN THE PATIENT'S TISSUE. EXTENSIVE PALPATION DID NOT REVEAL NEEDLE PIECE. X-RAYS WERE DONE SHOWING LOCATION OF PIECE OF NEEDLE. PIECE OF NEEDLE WAS RETRIEVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COLOSTOMY TAKE-DOWN AND HERNIA REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135862 PDS SUTURE, SURGICAL, ABSORBABLE GAS ETHICON, INC 2-0 27" SH 26 MM 1/2C TAPER *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR