BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 225227 · Received May 28, 1999

    Report

    Report Number
    2210968-1999-00306
    Event Type
    Injury
    Date Received
    May 28, 1999
    Report Date
    April 16, 1999
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FORTY TO 50 DAYS POST-OP, THE PT 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 PT WORE A CAST FROM THE ANKLE TO THE GROIN. THERE WERE NO SIGNS OF REACTION/INFECTION UNTIL THE CAST WAS REMOVED AND THE PT STARTED PHYSICAL THERAPY. THE JOINT BECAME SWOLLEN, AND THE SUTURE SITES WERE RED WITH PUS COMING OUT OF THEM. THE PT WAS ADMINISTERED ORAL ANTIBIOTICS AND THE SURGEON DID AN ARTHROSCOPIC WASHING PROCEDURE. THE PT 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 51 YR Required Intervention