BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DUALMESH BIOMATERIAL

    MDR report key: 1033688 · Received April 25, 2008

    Report

    Report Number
    3003910212-2008-00006
    Event Type
    Death
    Date Received
    April 25, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 25, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER INFORMATION WAS SUPPLIED THEREFORE A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE PERFORMED. THE REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE COMPLETED BECAUSE NO LOT NUMBER INFORMATION WAS SUPPLIED. WITHOUT ADDITIONAL INFORMATION, A MEANINGFUL INVESTIGATION CAN NOT BE PERFORMED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    GORE RECEIVED A COPY OF A LETTER DIRECTED TO THE FDA/CDRH MEDICAL DEVICE REPORTING OFFICE. THE LETTER FROM SR. FIELD ASSURANCE ENGINEER OF DAVOL INC., INDICATED THAT VIA DAVOL'S COMPLAINT PROCESS, DAVOL HAS BECOME AWARE OF A POSSIBLE REPORTABLE INCIDENT INVOLVING A MESH PRODUCT NOT MANUFACTURED BY DAVOL. THE PRODUCT WAS IDENTIFIED AS A GORE-TEX MESH (NO LOT NUMBER INFORMATION PROVIDED). IT IS UNCLEAR AS TO THE REASON OR CIRCUMSTANCES WHY THE DEVICE WAS EXPLANTED. NO EXPLANT IS AVAILABLE FOR EXAMINATION. NO LOT NUMBER INFORMATION WAS PROVIDED. GORE HAS MADE THE DECISION TO REPORT THIS INCIDENT BECAUSE THE MESH WAS REPORTED BY THE PATIENT AS REQUIRING EXPLANT/REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DUALMESH BIOMATERIAL SURGICAL MESH FTL W.L. GORE & ASSOCIATES,INC WLG101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention