BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 17963983 · Received October 19, 2023

    Report

    Report Number
    1213643-2023-00373
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 15, 2022
    Report Date
    October 3, 2023
    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 INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE JOURNAL ARTICLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE IS NO INDICATION THAT THE POSTOPERATIVE COMPLICATIONS IDENTIFIED IN THE ARTICLE WERE DUE TO THE USE OF THE DEVICE TO TREAT THE PATIENT CONDITION. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY/USE OF THE DEVICE AND IS INCLUDED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS ESTIMATED AS (B)(6) 2022 BASED ON THE AVAILABLE INFORMATION. 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. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "BIOLOGIC VS SYNTHETIC MESH FOR PARASTOMAL HERNIA REPAIR: POST HOC ANALYSIS OF A MULTICENTER RANDOMIZED CONTROLLED TRIAL." THE ARTICLE DESCRIBES A POST HOC ANALYSIS OF PARASTOMAL HERNIA REPAIRS RELATED TO 108 PATIENTS IN A RANDOMIZED TRIAL COMPARING BIOLOGIC AND SYNTHETIC MESH IN CONTAMINATED VENTRAL HERNIA REPAIRS OCCURRING AT 5 ACADEMIC MEDICAL CENTERS. 57 OF THE STUDY PATIENTS RECEIVED A NON-BARD/BD BIOLOGIC MESH AND 51 RECEIVED A SYNTHETIC BARD/BD SOFT MESH. DURING THE 2 YEAR STUDY FOLLOW-UP PERIOD THE PATIENTS IN THE SOFT MESH (SYNTHETIC) GROUP WERE REPORTED TO HAVE THE FOLLOWING INDICATIONS FOR REOPERATION: UNSPECIFIED INTRAABDOMINAL PATHOLOGY (5), WOUND COMPLICATION (4), VENTRAL HERNIA RECURRENCE (6), BOWEL OBSTRUCTION (1), PARASTOMAL HERNIA RECURRENCE (5). THE ARTICLE DOES NOT REPORT ANY DEVICE SPECIFIC ISSUE RELATED TO THE HERNIA REPAIR DEVICES; HOWEVER, THE ARTICLE DOES NOTE THAT THE ¿STUDY FOUND THE SAME INCIDENCE OF MESH EROSIONS IN BOTH GROUPS. NOTABLY, ALL MESH EROSIONS OCCURRED IN PATIENTS WITH A CRUCIATE MESH CONFIGURATION. THESE EROSIONS WERE MOST LIKELY TECHNICAL ERRORS¿. THE AUTHORS CONCLUDED THEIR ¿POST HOC ANALYSIS FOUND THAT BIOLOGIC AND SYNTHETIC MESH PERFORM SIMILARLY REGARDING OUR SAFETY OUTCOMES: WOUND MORBIDITY, REOPERATION, AND MESH EROSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738625 BARD SOFT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention