BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL

    MDR report key: 8745606 · Received June 28, 2019

    Report

    Report Number
    8745606
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 16, 2019
    Report Date
    June 19, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REPAIR OF A 2ND DEGREE PERINEAL LACERATION, THE SUTURE PULLED OFF THE NEEDLE WHILE REPAIRING THE TOP PORTION OF THE 2ND DEGREE. AFTER ASSESSING THE PATIENT'S VAGINA, THE NEEDLE WAS FOUND AT THE APEX (SLIGHTLY DEEP) OF THE 2ND DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538720 COATED VICRYL SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. VCP416H KL2012

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA