BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® BIO-A® TISSUE REINFORCEMENT

    MDR report key: 17148633 · Received June 16, 2023

    Report

    Report Number
    3003910212-2023-01467
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 17, 2023
    Report Date
    August 1, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    OXF
    PMA / PMN Number
    K033671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G3 / G4 PMA/510(K)NUMBER: CORRECTED PMA/510(K)NUMBER.

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE: CORRECTED TO G04053.

    Additional Manufacturer Narrative · 0

    PER THE GORE® BIO-A® TISSUE REINFORCEMENT INSTRUCTIONS FOR USE (IFU) POSSIBLE ADVERSE EVENTS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS OR SOFT TISSUE REINFORCEMENT SURGICAL PROCEDURES MAY INCLUDE, BUT ARE NOT LIMITED TO, ADDITIONAL INTERVENTION INCLUDING SURGERY AND SEROMA. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT A SURGEON REPORTED A SEROMA WITH A GORE® BIO-A® TISSUE REINFORCEMENT. IT WAS FURTHER REPORTED THAT A FS2030E GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED LAST YEAR. IT WAS A VENTRAL HERNIA REPAIR AND THE IMPLANTING SURGEON BELIEVES THERE WAS A SEROMA A FEW WEEKS LATER. THE DOCTOR PUT DRAINS IN AND SAID THEY WERE REMOVED TOO EARLY. A BREAST SURGEON LATER REMOVED THE MESH AND THE IMPLANTING SURGEON SAID THE BREAST SURGEON SHOULD NOT HAVE REMOVED THE DEVICE. THERE WAS NO FURTHER INFORMATION GIVEN. THE LOT NUMBER AND PATIENT INFORMATION WAS NOT RECALLED BY THE SURGEON AND HE STATED HE WAS NOT CONCERNED ABOUT THE EVENT. IT IS UNKNOWN WHERE THE DEVICE IS AND SO IT IS UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458315 GORE® BIO-A® TISSUE REINFORCEMENT MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY OXF W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention