BEUDAMED
    FDA Adverse Event Other Summary report: N

    VICRYL 2 0 CT 3

    MDR report key: 530368 · Received June 16, 2004

    Report

    Report Number
    530368
    Event Type
    Other
    Date Received
    June 16, 2004
    Date of Event
    April 14, 2004
    Report Date
    April 26, 2004
    Manufacturer
    ETHICON, JOHNSON & JOHNSON
    Product Code
    GAM
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS CLOSING UMBILICUS INCISION WITH 2-0 VICRYL CT SUTURES WHEN THE NEEDLE BROKE OFF. SURGEON ATTEMPTED TO LOCATE NEEDLE IN THE INCISION. THE C-ARM WAS USED TO LOCATE THE NEEDLE. A LARGER INCISION WAS MADE TO EXPLORE THE ABDOMEN AND RETRIEVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL 2 0 CT 3 SUTURE GAM ETHICON, JOHNSON & JOHNSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other