BEUDAMED
    FDA Adverse Event Summary report: N

    ABSORBABLE GUT SURGICAL SUTURE

    MDR report key: 73014 · Received March 4, 1997

    Report

    Report Number
    MW4001790
    Date Received
    March 4, 1997
    Report Date
    February 7, 1997
    Manufacturer
    LUKENS MEDICAL CORP.
    Product Code
    GAL
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SUTURE IS COMPLETELY DRY WHEN THE PACKAGE IS OPENED. CHROMIC SUTURE IS PACKAGED IN A LIQUID TO PREVENT IT FROM DRYING OUT. THERE IS NO LIQUID IN THIS SUTURE WHICH CAUSES THE SUTURE TO BECOME BRITTLE AND BREAK WHEN KNOTS ARE TIED. ALSO, THE FOIL LOOKS LIKE IT IS DETERIORATING AND COULD CAUSE A QUESTION ABOUT THE SUTURES STERILITY. THERE ARE ALSO BUBBLES IN THE FOIL AROUND THE SEAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBABLE GUT SURGICAL SUTURE Implant CHROMIC GUT SURGICAL SUTURE GAL LUKENS MEDICAL CORP. * 0493/021

    Patients

    Seq Age Sex Outcome Treatment
    1 *