BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH ¿ DULEX

    MDR report key: 21696076 · Received March 26, 2025

    Report

    Report Number
    1213643-2025-090136
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    October 30, 2008
    Report Date
    March 26, 2025
    Manufacturer
    BRIDGER BIOMED, INC. -3031159
    Product Code
    FTL
    UDI-DI
    00801741011924
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 1YEAR 8 MONTHS POST IMPLANT OF MESH ¿ DULEX, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS AND MESH DEFORMATION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AND ADHESIONS AS POSSIBLE COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE MESH ¿ DULEX (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE MESH ¿ COMPOSIX (DEVICE #1) AND AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH(DEVICE #3). 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) 2001 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED, AND A COMPOSIX MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LYSIS OF ADHESIONS WAS PERFORMED. A DUAL MESH (DEVICE #2) WAS PLACED AND TACKED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX MESH (DEVICE #1) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) WAS FOUND DISRUPTED FROM THE ANTERIOR ABDOMINAL WALL WAS EXCISED COMPLETELY AND REMOVED. THE MESH (DEVICE #2) ON THE RIGHT SIDE WAS FOUND IN GOOD POSITION. A BIOLOGICAL MESH WAS PLACED AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF DULEX MESH (DEVICE #2) AND BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS REDUCED. LYSIS OF ADHESIONS WAS PERFORMED. THE MESH (DEVICE #2) AND BIOLOGICAL MESH FOUND DISRUPTED OVER THE DEFECT WERE DISSECTED AND REMOVED." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT VENTRAL HERNIAS AND RIGHT SIDED SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿LYSIS OF ADHESIONS WAS PERFORMED. A BARD FLAT MESH (DEVICE #3) WAS PLACED TO COVER ALL THE DEFECT AND SUTURED." ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL PERFORATION, MESH MIGRATION, PAIN AND HERNIA RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093225 MESH ¿ DULEX SURGICAL MESH FTL BRIDGER BIOMED, INC. -3031159 NA NI 00801741011924

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention