BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DMAX LIGHT

    MDR report key: 23082502 · Received September 18, 2025

    Report

    Report Number
    1213643-2025-00864
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 1, 2018
    Report Date
    September 5, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K091659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 POSTOPERATIVE COMPLICATIONS OF SEROMA FORMATION AND INFECTION. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE 3DMAX LIGHT MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SEROMA FORMATION AND INFECTION ARE LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." NOTE, THE DATE OF EVENT (01-AUG-2018) 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: "SUBCUTANEOUS FAT THICKNESS PREDICTS POSTOPERATIVE SEROMA FOLLOWING LAPAROSCOPIC TOTAL EXTRA-PERITONEAL HERNIOPLASTY." A RETROSPECTIVE STUDY REVIEWED DATA OF 229 MALE PATIENTS WHO UNDERWENT LAPAROSCOPIC TOTAL EXTRA-PERITONEAL (TEP) HERNIOPLASTY FOR INDIRECT INGUINAL HERNIA BETWEEN AUGUST 2018 AND JULY 2021. THE TSF WAS ASSESSED USING PREOPERATIVE ULTRASOUND IMAGES. A SELF-ADHESIVE LARGE-SIZED (10.3 × 15.7 CM) LIGHTWEIGHT POLYPROPYLENE MESH (BARD 3DMAX, BD, USA). THE POSTOPERATIVE COMPLICATIONS INCLUDES SEROMA: 26 (11.4%); MESH INFECTION: 1 (3.8%) WITH COMPLETE REMOVAL OF MESH THOROUGH, IRRIGATION, AND SURGICAL DRAINAGE AND 22 WITHOUT ANY INTERVENTION. THIS STUDY DEMONSTRATES THAT THE AI MODEL ACCURATELY IDENTIFIED KEY ANATOMIC LANDMARKS IN TAPP AND SHOWED VALIDITY IN SURGEON¿S ASSESSMENT. 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 MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598915 3DMAX LIGHT SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention