BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DUALEMESH BIOMATERIAL

    MDR report key: 1033917 · Received April 24, 2008

    Report

    Report Number
    3003910212-2008-00005
    Event Type
    Death
    Date Received
    April 24, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 23, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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. NOTE: 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

    IT WAS ALLEGED TO GORE IN A LAWSUIT, THAT IN 2006, THE PATIENT HAD "A LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA WITH MESH PLACEMENT" AND THAT THE "POST OPERATIVE DIAGNOSIS WAS STATUS POST REDUCTION OF INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL RESECTION." THE PLAINTIFF FURTHER ALLEGES THAT "DURING THIS PROCEDURE, A LAPAROSCOPIC ABDOMINAL WALL HERNIA REPAIR WAS PERFORMED USING A LARGE 20 X 30 CENTIMETER DUALMESH MANUFACTURED AND SOLD EITHER BY DEFENDANT DAVOL, INC., OR C.R. BARD, INC., OF W.L. GORE & ASSOCIATES, INC." THE COMPLAINANT ALLEGES, THAT AS A RESULT OF THE DEFENDANTS' CONDUCT, THE PATIENT SUFFERED SEVERAL INJURIES AND THAT HE ULTIMATELY DIED AS A RESULT OF THESE INJURIES. GORE HAS NO OTHER INFORMATION AT THIS POINT AND DOES NOT KNOWN IF THE PRODUCT DESCRIBED IN PLAINTIFFS' LAWSUIT IS A PRODUCT MANUFACTURED AND SOLD BY GORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death