BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL

    MDR report key: 2250834 · Received September 7, 2011

    Report

    Report Number
    2250834
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 7, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL EYE MUSCLE CASE, THE SURGEON WAS PASSING A 6-0 VICRYL SUTURE, J556G THRU THE LEFT MEDIAL RECTUS MUSCLE WHEN HE NOTED THAT THE SUTURE BEGAN TO FRAY AND SPLIT IN HALF. THE SUTURE WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW SUTURE. THE SUTURE REPRESENTATIVE WAS NOTIFIED. NO HARM TO THE PATIENT OCCURRED, AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL SUTURE, ABSORBABLE GAM ETHICON, INC. J556G DGZ050

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR