BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 22953190 · Received September 3, 2025

    Report

    Report Number
    1213643-2025-00811
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    December 1, 2012
    Report Date
    August 27, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K052155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS OF HERNIA RECURRENCE, OBSTRUCTION AND SURGICAL INTERVENTION. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE SOFT MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: MESH-RELATED OUTCOMES OF BIOLOGIC VERSUS SYNTHETIC MESH FOR SINGLE-STAGE REPAIR OF CONTAMINATED VENTRAL HERNIAS: A FIVE TO TEN YEAR ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL THIS RETROSPECTIVE CASE¿CONTROL STUDY WAS CONDUCTED INCLUDING 253 PATIENTS INITIALLY RANDOMIZED IN THE MULTI-CENTER TRIAL (127 BIOLOGIC MESH, 126 SYNTHETIC MESH), OF THESE 203 (105 BIOLOGIC, 98 SYNTHETIC) COMPLETED A MINIMUM OF FIVE-YEAR FOLLOW-UP. THIS MULTI-CENTER PROSPECTIVE, SINGLE-BLINDED RANDOMIZED CONTROLLED PARALLEL-GROUP TRIAL COMPARED THE USE OF BIOLOGIC MESH (STRATTICE RECONSTRUCTIVE TISSUE MATRIX) VERSUS MEDIUM-WEIGHT POLYPROPYLENE SYNTHETIC MESH (BARD SOFT MESH) FROM DECEMBER 2012 TO APRIL 2019. TWO YEARS FOLLOW UP WAS COMPLETED IN 2021 THUS PROVIDING A MINIMUM OF FIVE-YEAR FOLLOW-UP FOR ALL PARTICIPANTS IN THIS EXTENDED STUDY THROUGH APRIL 2024. POSTOPERATIVE COMPLICATIONS, INCLUDING PARASTOMAL HERNIA RECURRENCE 7; SMALL BOWEL OBSTRUCTION 4. SYNTHETIC MESH PROVIDES SUPERIOR LONG-TERM RECURRENCE OUTCOMES WITHOUT INCREASED MESH-RELATED COMPLICATIONS IN CLEAN-CONTAMINATED AND CONTAMINATED REPAIRS WHEN COMPARED TO BIOLOGIC MESH. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386547 BARD SOFT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention