BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH ¿ DULEX

    MDR report key: 22021480 · Received May 14, 2025

    Report

    Report Number
    1213643-2025-090208
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    May 25, 2012
    Report Date
    May 14, 2025
    Manufacturer
    BRIDGER BIOMED, INC. -3031159
    Product Code
    FTL
    UDI-DI
    00801741011795
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE IS INCONCLUSIVE, NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. THIS EMDR REPRESENTS THE BARD/DAVOL MESH ¿ DULEX (DEVICE #3). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE BARD/DAVOL MESH ¿ COMPOSIX L/P (DEVICE #1 & #2) AND BARD/DAVOL MESH ¿ VENTRALEX (DEVICE #4). 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 INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO COMPOSIX L/P (DEVICE # 1 & # 2). PER OP NOTES, ¿TWO COMPOSIX L/P MESH (DEVICE #1 & #2) WERE PLACED WITHIN THE ABDOMEN AND TACKED TO THE LEFT ASPECT OF THE HERNIA USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE # 3). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. A DULEX MESH (DEVICE # 3) WAS PLACED IN THE ABDOMEN AND TACKED TO THE OVERLYING PERITONEUM USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED COMPOSIX L/P (DEVICE #1 & #2) DURING THIS REPAIR). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #4). PER OP NOTES, ¿A SMALL DEFECT WAS NOTED IN THE LEFT LOWER QUADRANT WHERE TWO PREVIOUS PLACED MESHES (DEVICE # 1 & # 2) COME TOGETHER. A VENTRALEX MESH (DEVICE #4) WAS PLACED IN THE ABDOMEN AND TACKED OVER TO OVERLIE THE DEFECT.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED DULEX MESH (DEVICE # 3) DURING THIS REPAIR). (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INFECTED MESH FROM INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1, #2, #3 & #4). PER OP NOTES, ¿THE ABDOMEN WAS ENTERED, AND A LARGE PIECE OF MESH WAS ENCOUNTERED AND AN EXTENSIVE ADHESIOLYSIS WAS PERFORMED. THE MESH (DEVICE #1, #2, #3 & #4) WAS THEN REMOVED. THERE WAS NOTED TO BE AN ABSCESS CAVITY IN THE LATERAL LEFT ASPECT OF THE MESH.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089599 MESH ¿ DULEX SURGIAL MESH FTL BRIDGER BIOMED, INC. -3031159 NA BRSK8315 00801741011795

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention