BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6-0 POLYPROPYLENE SUTURE

    MDR report key: 14508 · Received January 10, 1994

    Report

    Report Number
    2242352-1994-00001
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    October 25, 1993
    Report Date
    November 1, 1993
    Manufacturer
    LUKENS MEDICAL CORP.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE IMPLANTING OF THE SUTURE, THE SUTURE BEGAN TO FRAY. THE DOCTOR ELECETED TO REMOVE THE IMPLANTED SUTURES. THE PATIENT'S CONDITION IS FINE. THE EXPLANTED SUTURES WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6-0 POLYPROPYLENE SUTURE Implant SUTURE GAW LUKENS MEDICAL CORP. NA BA11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention