BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 61811 · Received January 9, 1997

    Report

    Report Number
    61811
    Event Type
    Injury
    Date Received
    January 9, 1997
    Date of Event
    December 6, 1996
    Report Date
    December 9, 1996
    Manufacturer
    W.L. GORE & ASSO. INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSP SUBMITS THIS REPORT PURSUANT TO 21CFR803. IT IS BASED ON INFO REVIEWED WHICH HOSP MAY NOT HAVE HAD AN OPPORTUNITY TO INVESTIGATE FULLY OR VERIFY PRIOR TO REPORTING DATE. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION THAT HOSP OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN. HAVING JUST FINISHED CAROTID SURGERY, AREA WAS CLOSED AND DRESSED & PT EXTUBATED BUT NOT YET MOVED TO STRETCHER WHEN SWELLING WAS NOTED & AREA BEGAN TO BLEED. AREA REOPENED & REPAIR ATTEMPTED WITH 7-0 SUTURE BUT SUTURES KEPT BREAKING. AREA FINALLY CLOSED WITH 6-0 SUTURE. PT REQUIRED EMERGENCY TRACHEOSTOMY TO MAINTAIN AIRWAY. PT CURRENTLY DOING FINE. ORIGINAL CLOSURE WAS DONE ALSO WITH 7-0 SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant 7-0 SUTURE GAW W.L. GORE & ASSO. INC. * 9110A42,9303D42,9212B75

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R