BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DMAX

    MDR report key: 24306397 · Received February 10, 2026

    Report

    Report Number
    1213643-2026-00098
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    November 19, 2024
    Report Date
    January 22, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741030765
    PMA / PMN Number
    K081010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT HAD RIGHT SIDED ABDOMINAL PAIN POST-IMPLANT OF 3DMAX MESH AND APPROXIMATELY ONE YEAR LATER UNDERWENT AN ADDITIONAL SURGERY AND WAS IMPLANTED WITH A NON-BD MESH. CONTACT REPORTS PAIN ON THE LEFT SIDE, HOWEVER IT IS LESS SEVERE. CONTACT INFORMATION WAS NOT PROVIDED AS SUCH REQUESTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE PAIN. PAIN IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. THIS EMDR REPRESENTS THE 3DMAX RIGHT MESH (DEVICE 2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE 3DMAX LEFT MESH (DEVICE 1). 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

    AS REPORTED BY PATIENT VIA ANSM REPORT (N° R2601107): "I HAD MY FIRST SURGERY ON (B)(6) 2023, FOR A LEFT AND RIGHT INGUINAL HERNIA. A BECTON DICKINSON 3DMAX MESH WAS PLACED ON EACH SIDE OF MY ABDOMEN. FOLLOWING PAIN ON THE RIGHT SIDE, I UNDERWENT A SECOND OPERATION ON (B)(6) 2024. A COUSIN BIOSERV BIOMESH PLATE WAS PLACED, BUT THE PAIN IS STILL PRESENT ON THE RIGHT SIDE. THERE IS ALSO PAIN ON THE LEFT SIDE, BUT IT IS LESS SEVERE." ON (B)(6) 2023, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR BY LAPAROSCOPIC APPROACH (MHJ) AND IMPLANTED WITH 3DMAX MESH LEFT AND RIGHT. ON (B)(6) 2024, A LICHTENSTEIN BIOMESH A2 PLATE WAS IMPLANTED. CURRENT PATIENT STATUS: NR. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR. THIS REPORT REPRESENTS DEVICE #2 (3DMAX-RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364827 3DMAX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUHQ0761 00801741030765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention