BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 641595 · Received October 18, 2005

    Report

    Report Number
    2210968-2005-00620
    Event Type
    Injury
    Date Received
    October 18, 2005
    Date of Event
    June 19, 1994
    Report Date
    October 3, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN ARTHROSCOPIC MENISCAL REPAIR OF THE MEDIAL MENISCUS OF THE RIGHT KNEE ON 06/14/1994. THREE PORTAL SITES WERE MADE AND THE IRRIGATION TROCAR WAS INTRODUCED. THE PROBE WAS INSERTED AND A SMALL CENTRAL TEAR WAS DEBRIDED WITH THE ARTHROTOMA AND PUNCH FORCEPS. SIZE 2-0 ABSORBABLE SUTURES WERE PLACED INTO THE MENISCUS FROM THE MEDIAL ENTRY SITE IN THE USUAL FASHION AND TIED DOWN INTO PLACE AND STABILIZED THE MENISCUS. THE PORTAL SITES WERE APPROX WITH NYLON SUTURES. PT TOLERATED PROCEDURE WELL, AND WAS DISCHARGED. THE PT PROSENTED TO THE ER ON 06/19/1994 COMPLAINING OF PAIN AND SWELLING. WBC 21.7. THE PT RETURNED TO SURGERY ON 06/19/1994, AND THE KNEE WAS EXPLORED; THE MENISCUS WAS DEBRIDED, THE WOUND WAS COPIOUSLY IRRIGATED, THE SUTURES WERE REMOVED, AND A DRAIN WAS PLACED BEFORE CLOSING. THE DRAIN REMAINED IN PLACE FOR 3 DAYS, WITH MINIMAL DRAINAGE. THE PT WAS TREATED WITH IV ANTIBIOTICS (GENTAMYCIN, ANCEF AND NAFCILLIN) AND DISCHARGED IN 06/1994, ON IV ANTIBIOTIC THERAPY (CEPHAZOLIN). THE WBC UPON DISCHARGE WAS 12.5. HE IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention