BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 24018814 · Received January 9, 2026

    Report

    Report Number
    1213643-2025-01331
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    April 1, 2019
    Report Date
    December 22, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741030932
    PMA / PMN Number
    K052155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. 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 BARD SOFT MESH. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA AND INFECTIONS AS POSSIBLE COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-APR-2019) IS CONSIDERED TO BE A BEST ESTIMATE. 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: "IMPACT OF TRANSVERSUS ABDOMINIS RELEASE (TAR) WITH BOTULINUM TOXIN (BTX) INJECTION VERSUS TAR WITHOUT BTX INJECTION ON QUALITY OF LIFE AND POSTOPERATIVE PAIN IN LARGE VENTRAL HERNIA REPAIR: A COMPARATIVE STUDY" THIS PROSPECTIVE COHORT STUDY INVESTIGATED WHETHER ADJUNCTIVE BOTULINUM TOXIN (BTX) INJECTION IMPROVES OUTCOMES IN PATIENTS UNDERGOING TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR LARGE VENTRAL HERNIA REPAIR. THE STUDY AIMED TO ASSESS POSTOPERATIVE PAIN, INTRA-ABDOMINAL PRESSURE (IAP), QUALITY OF LIFE, AND RECURRENCE RATES, WITH BARD SOFT MESH USED FOR ABDOMINAL WALL REINFORCEMENT. PATIENTS AGED 18 YEARS OR MORE WITH LARGE VENTRAL HERNIAS (DEFECT WIDTH 10 CM OR MORE) WERE INCLUDED. BTX WAS ADMINISTERED FOR DEFECTS MORE THAN 12 CM, SABBAGH'S INDEX 20% OR MORE, OR MILD TO MODERATE PULMONARY COMPROMISE. NINETY-SEVEN PATIENTS WERE ANALYZED (APRIL 2019-JUNE 2023): TAR+BTX GROUP (N-55) AND TAR-ONLY GROUP (N-42). ALL REPAIRS UTILIZED BARD SOFT MESH (30X30 CM) PLACED IN THE RETRO MUSCULAR PLANE. BTX INJECTIONS (200 UNITS BOTOX, ALLERGAN) WERE GIVEN FOUR WEEKS PREOPERATIVELY. OUTCOMES WERE ASSESSED OVER 12 MONTHS USING HERQLES SCORES, IAP MEASUREMENTS, PAIN SCORES, AND RECURRENCE MONITORING. MESH-RELATED COMPLICATIONS WERE MINIMAL. SURGICAL SITE OCCURRENCES (SSO) SUCH AS SEROMA, HEMATOMA, AND WOUND INFECTION OCCURRED IN 12.7% OF TAR+BTX AND 11.9% OF TAR-ONLY CASES, ALL MANAGED CONSERVATIVELY EXCEPT ONE REQUIRING DEBRIDEMENT. 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
    79663 BARD SOFT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741030932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other