BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SOFT TISSUE PATCH

    MDR report key: 1003012 · Received February 25, 2008

    Report

    Report Number
    2017233-2008-00085
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    AN EXPLANTED DEVICE WAS RETURNED TO GORE. IT IS UNCLEAR AS TO THE REASON OR CIRCUMSTANCES WHY THE DEVICE WAS EXPLANTED. GORE HAS BEEN UNABLE TO GAIN ADD'L INFO AT THIS TIME. GORE HAS MADE THE DECISION IN THE ABSCENCE OF ADD'L INFO TO REPORT THIS EVENT. SHOULD ADD'L INFO BECOME AVAILABLE, GORE WILL AMEND THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SOFT TISSUE PATCH PATCH FTL W.L. GORE & ASSOCIATES, INC. WLG101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention