BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 225513 · Received May 28, 1999

    Report

    Report Number
    2210968-1999-00308
    Event Type
    Malfunction
    Date Received
    May 28, 1999
    Report Date
    May 7, 1999
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FORTY TO 50 DAYS POST-OPERATIVE, THE PATIENT DEVELOPED A REACTION/INFECTION AFTER STARTING PHYSICAL THERAPY FOLLOWING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE. DURING THE PROCEDURE, THE SURGEON SUTURED THROUGH THE JOINT AND CAME OUT OF THE MEDIAL SIDE OF THE KNEE. THE PATIENT WORE A CAST FROM THE ANKLE TO THE GROIN. THERE WERE NO SIGNS OF THE REACTION/INFECTION UNTIL THE CAST WAS REMOVED AND THE PATIENT STARTED PHYSICLA THERAPY. THE JOINT BECAME SWOLLEN, AND THE SUTURE SITES WERE RED WITH PUS WAS COMING OUT OF THEM. THEPATIENT WAS ADMINISTERED ORAL ANTIBLOTICS AND RECOVERED FROM THE INFECTION. CULTURES WERE TAKEN BUT CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE Implant SUTURE, ABSORBABLE GAN ETHICON, INC. SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR