BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 223042 · Received May 11, 1999

    Report

    Report Number
    2017233-1999-00002
    Event Type
    Injury
    Date Received
    May 11, 1999
    Date of Event
    April 2, 1999
    Report Date
    May 11, 1999
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE FIRST EVENT OF 'UNTIED KNOTS', THE SURGEON ELECTED TO USE THE SAME TYPE OF SUTURE MATERIAL TO PREVENT SUTURE HOLE BLEEDING. FOLLOWING THE SECOND EPISODE OF 'UNTIED KNOTS', A DECISION WAS MADE TO USE A DIFFERENT SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE DTH W.L. GORE & ASSOCIATES,INC WLG605 97-46-B42

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention