BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DUALMESH® BIOMATERIAL

    MDR report key: 10829366 · Received November 12, 2020

    Report

    Report Number
    3003910212-2020-01133
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    December 31, 2004
    Report Date
    August 12, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K992189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF PMA/510K NUMBER TO K992189.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO SECTION C: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. ¿OPEN AND LAPAROSCOPIC APPROACH IN INCISIONAL HERNIA REPAIR WITH EPTFE PROSTHESIS¿, PUBLISHED BY GEORGE N. ZOGRAFOS ET AL, WITHIN THE JOURNAL OF LAPAROENDOSCOPIC AND ADVANCED SURGICAL TECHNIQUES, VOLUME 17, NUMBER 3, 2007, DOI: 10.1089/LAP.2006.0082. MULTIPLE ATTEMPTS HAVE BEEN MADE FROM GORE TO THE COMPLAINANT OVER AN EXTENDED PERIOD OF TIME IN ORDER TO GET ADDITIONAL INFORMATION. AS NO INFORMATION RELATED TO THIS COMPLAINT HAS BEEN OR WILL BE PROVIDED BY THE COMPLAINANT, THIS EVENT WILL BE CLOSED WITH THE INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ARE UNAVAILABLE, SO NO PRODUCT EVALUATION CAN BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) COULD NOT BE CONDUCTED BECAUSE THE SERIAL NUMBERS REMAIN UNKNOWN. PATIENT MEAN GENDER: FEMALE. PATIENT MEDIAN AGE: 20-87. PATIENT ID: GORE CASE NUMBER. EVENT DATE: STUDY WAS CLOSED IN (B)(6) 2004. THE AUTHOR WAS CONTACTED IN ORDER TO GET ADDITIONAL INFORMATION FOR THE REPORTED DEVICE INFECTIONS WITH CONSEQUENT DEVICE REMOVAL.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿OPEN AND LAPAROSCOPIC APPROACH IN INCISIONAL HERNIA REPAIR WITH EPTFE PROSTHESIS¿, PUBLISHED BY GEORGE N. ZOGRAFOS ET AL, WITHIN THE JOURNAL OF LAPAROENDOSCOPIC AND ADVANCED SURGICAL TECHNIQUES, VOLUME 17, NUMBER 3, 2007, DOI: 10.1089/LAP.2006.0082, THE ARTICLE INDICATES THE FOLLOWING: THE AIM OF THE RETROSPECTIVE STUDY WAS TO ANALYZE THE RESULTS OF INCISIONAL HERNIA LAPAROSCOPIC AND OPEN SURGERY, FOCUSING ON THE MORBIDITY AND POSTOPERATIVE IMPLICATIONS. A GROUP OF 106 (42 MEN, 64 WOMEN) PATIENTS SUFFERING FROM INCISIONAL HERNIAS WERE TREATED WITH EITHER A LAPAROSCOPIC (30) OR AN OPEN (76) PLACEMENT OF A PROSTHETIC MESH BETWEEN JANUARY 1997 AND DECEMBER 2004. AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) MESH WAS USED IN 103 PATIENTS, WHEREAS A POLYPROPYLENE MESH WAS USED IN 3 PATIENTS. IN THE OPEN TECHNIQUE, 3 PATIENTS WITH THE EPTFE PROSTHETIC MATERIAL DEVELOPED A MESH INFECTION AND REQUIRED A MESH REMOVAL, WHICH WAS EASILY PERFORMED UNDER LOCAL ANESTHESIA. ONE OF THESE PATIENTS PRESENTED WITH WOUND ABSCESS AND A MESH INFECTION 18 MONTHS FOLLOWING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298245 GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC FTL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention