BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3003996 · Received November 14, 2008

    Report

    Report Number
    2017233-2008-00875
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    April 21, 2008
    Report Date
    November 14, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT HIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    GORE RECEIVED INFO INDICATING THIS PT UNDERWENT A SECOND PROCEDURE. FURTHER INVESTIGATION IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 03942456

    Patients

    Seq Age Sex Outcome Treatment
    1