BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 255124 · Received December 15, 1999

    Report

    Report Number
    2017233-1999-00008
    Event Type
    Injury
    Date Received
    December 15, 1999
    Date of Event
    November 16, 1999
    Report Date
    December 15, 1999
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A "SPAIR" PROCEDURE. APPROXIMATELY 2 WEEKS POSTOPERATIVELY, THE PT WAS READMITTED FOR A SECOND SURGERY BECAUSE THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED AND THE PT IS DOING FINE. THE SURGEON WAS NOT UPSET WITH THE PRODUCT PERFORMANCE; RATHER HE INDICATED THAT HE SHOULD HAVE USED A LARGER SUTURE THREAD SIZE, TO ACCOMMODATE THIS LARGE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE DTH W.L. GORE & ASSOCIATES,INC WLG604 9914C22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention