BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 76433 · Received March 12, 1997

    Report

    Report Number
    2017233-1997-00009
    Event Type
    Injury
    Date Received
    March 12, 1997
    Report Date
    March 12, 1997
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON IN ANOTHER COUNTRY REPORTED PERFORMING AN ABDOMINAL PROCEDURE WITH THE MFR'S DEVICE ON AN UNK DATE. IT IS REPORTED THAT THE PT COUGHED POSTOPERATIVELY AND UPON REOPERATION, THE SURGEON ALLEGES THAT THE SUTURE APPEARED BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE GAW W.L. GORE & ASSOCIATES, INC. WLG600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention