BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL

    MDR report key: 17526971 · Received August 12, 2023

    Report

    Report Number
    MW5133908
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    August 30, 2012
    Manufacturer
    W. L. GORE AND ASSOCIATES, INC.
    Product Code
    FTM
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    STRATTICE WAS USED FOR AN ABDOMINAL WALL RECONSTRUCTION PROCEDURE ALONG WITH BIOA. THE STRATTICE REINFORCED MIDLINE PRIMARY CLOSURE AS INTRAPERITONEAL UNDERLAY TO REPAIR THE THIRTEENTH RECURRENCE OF INCISIONAL VENTRAL HERNIA. BIO-A 9X15 FS0915 REINFORCED LEFT LOWER QUADRANT PRIMARY CLOSURE AS INTRA PERITONEAL UNDERLAY THIRD RECURRENCE OF FLANK HERNIA. THE PATIENT REHERNIATED IN (B)(6) 2012. THE LEFT LOWER QUADRANT WHERE THE BIO-A HAD BEEN PLACED WAS THE ONLY RECURRENCE SITE. IT WAS REPORTED THAT WHEN THE DOCTOR RE-OPERATED, IT WAS THE BIO-A THAT FAILED AND NOT THE STRATTICE. L TM SURGICAL MESH (STRATTICE) (K070560) IS MANUFACTURED BY US, THE LIFECELL? CORPORATION, WHILE THE OTHER PRODUCT MENTIONED IN THE COMPLAINT, BIOA, IS MANUFACTURED BY GORE MEDICAL. THE LIFECELL CORPORATION HAS REVIEWED AND EVALUATED THIS COMPLAINT, AND AFFIRMS THAT OUR PRODUCT, STRATTICE, IS NOT RELATED TO THE EVENT REPORTED IN THE COMPLAINT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870536 MESH, SURGICAL MESH, SURGICAL FTM W. L. GORE AND ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown