BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DUALMESH® BIOMATERIAL

    MDR report key: 10829376 · Received November 12, 2020

    Report

    Report Number
    3003910212-2020-01134
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    June 30, 1998
    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)]. ¿SURGICAL REPAIR OF INCISIONAL VENTRAL HERNIAS: TENSION-FREE TECHNIQUE USING PROSTHETIC MATERIALS (EXPANDED POLYTETRAFLUOROETHYLENE GORE-TEX DUAL MESH)¿, PUBLISHED BY EMMANUEL CHRYSOS ET AL, WITHIN THE JOURNAL THE AMERICAL SURGEON, VOLUME 66, JULY 2000, PAGE 679-682. 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 · 0

    UPDATED PRODUCT NAME FROM SOFT TISSUE PATCH TO DUALMESH DEVICE.

    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: 65 (28-87). PATIENT ID: CASE NUMBER. EVENT DATE: STUDY WAS CLOSED IN (B)(6) 1998. THE AUTHOR WAS CONTACTED IN ORDER TO GET ADDITIONAL INFORMATION FOR THE REPORTED WOUND INFECTIONS WITH CONSEQUENT DEVICE REMOVAL.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿SURGICAL REPAIR OF INCISIONAL VENTRAL HERNIAS: TENSION-FREE TECHNIQUE USING PROSTHETIC MATERIALS (EXPANDED POLYTETRAFLUOROETHYLENE GORE-TEX DUAL MESH)¿, PUBLISHED BY EMMANUEL CHRYSOS ET AL, WITHIN THE JOURNAL THE AMERICAL SURGEON, VOLUME 66, JULY 2000, PAGE 679-682, THE ARTICLE INDICATES THE FOLLOWING: THE PURPOSE OF THE STUDY WAS TO REPORT THE RESULTS OF A TENSION-FREE REPAIR TECHNIQUE USING EXPANDED POLYTETRAFLUOROETHYLENE GORE-TEX DUAL MESH (GORE-TEX SOFT TISSUE PATCH, W.L. GORE AND ASSOCIATES INC, FLAGSTAFF, AZ) IN PATIENTS WITH PRIMARY OR RECURRENT INCISIONAL VENTRAL HERNIAS. FROM JUNE 1995, THROUGH JUNE 1998, 52 PATIENTS WITH INCISIONAL HERNIAS HAVE UNDERGONE THIS PROCEDURE IN THE CLINIC. FOURTEEN OF THEM HAD RECURRENT HERNIAS WHICH HAD BEEN PRIMARILY REPAIRED BY MAYO HERNIOPLASTY. SIX OF THE PATIENTS HAD IRREDUCIBLE HERNIAS PREOPERATIVELY. TWENTY-FIVE PATIENTS HAD HERNIAS ON MIDLINE INCISIONS, AND THE REST OF THEM HAD HERNIAS ON TRANSVERSE ABDOMINAL INCISIONS. FOUR OF THE PATIENTS EXPERIENCED WOUND INFECTION AND WERE TREATED BY MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298618 GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC FTL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention