BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH ¿ DULEX

    MDR report key: 21879150 · Received April 22, 2025

    Report

    Report Number
    1213643-2025-090163
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    September 11, 2019
    Report Date
    April 22, 2025
    Manufacturer
    BRIDGER BIOMED, INC. -3031159
    Product Code
    FTL
    UDI-DI
    00801741011856
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 YEARS 9 MONTHS POST IMPLANT OF DULEX MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND ADHESIONS THEREBY UNDERWENT REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AND ADHESIONS AS POSSIBLE COMPLICATIONS. THIS EMDR REPRESENTS THE MESH ¿ DULEX (DEVICE #3). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE MESH ¿ COMPOSIX KUGEL (DEVICE #1 & #2). 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 BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH VENTRAL AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRAL HERNIA SAC WAS REDUCED AND PUSHED BACK. THE UMBILICAL SAC ALSO REDUCED. BOTH DEFECTS WERE THEN COVERED WITH AN COMPOSIX KUGEL (DEVICE #1) AND TACKED." ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF COMPOSIX KUGEL (DEVICE #1) AND IMPLANT OF COMPOSIX KUGEL (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC NOTED TO THE LEFT OF MIDLINE WAS EXCISED. THE PREVIOUSLY PLACED MESH (DEVICE #1) DISPLACED LATERALLY TO THE RIGHT WAS EXCISED AND REMOVED COMPLETELY. A COMPOSIX KUGEL (DEVICE #2) WAS PLACED AND TACKED." ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH BOWEL OBSTRUCTION SECONDARY TO WADDED UP MESH (DEVICE #2) THEREBY UNDERWENT PARTIAL EXPLANT OF COMPOSIX KUGEL (DEVICE #2). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #2) HAD BECOME FOLDED OVER UPON ITSELF AND THERE WERE DENSE ADHESIONS OF SMALL BOWEL AT FOCAL POINT OF OBSTRUCTION. ADHESIONS WERE TAKEN DOWN. THE MESH (DEVICE #2) ON THE ABDOMINAL WALL SIDE WAS EXCISED, THE MESH ON THE OPPOSITE SIDE APPEARED TO BE INTACT WAS LEFT. ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿SOME REMNANT OF OLD MESH (DEVICE #2) APPEARED TO BE WELL INCORPORATED. ADHESIOLYSIS WAS PERFORMED, ALL FASCIAL DEFECTS WERE EXPOSED, AND A DULEX MESH (DEVICE #3) WAS PLACED AND SUTURED." ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿ADHESIONS AROUND THE HERNIA ARE REMOVED AND A PRIMARY REPAIR WAS DONE USING SUTURES." ON (B)(6) 2019: PATIENT WAS DIAGNOSED WITH MULTIPLE ABDOMINAL WALL RECURRENT HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE EXPLANT OF COMPOSIX KUGEL (DEVICE #2) AND DULEX MESH (DEVICE #3) AND IMPLANT OF TWO VENTRALIGHT ST MESH (DEVICE #4 & DEVICE #5). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED MESHES (DEVICE #2 & #3) WERE COMPLETELY DISSECTED AWAY AND REMOVED. ADHESIONS WERE TAKEN DOWN. A LARGE HERNIA IN THE RIGHT LOWER QUADRANT WAS PLACED OBLIQUELY WITH VENTRALIGHT ST MESH (DEVICE #4) AND SUTURED. A SECOND VENTRALIGHT ST MESH (DEVICE #5) WAS PLACED SUPERIORLY WHERE SUBXIPHOID HERNIA IS PRESENT AND SUTURED." ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, BOWEL PERFORATION, MESH MIGRATION, PAIN, HERNIA RECURRENCE, MESH FOLDED AND MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353322 MESH ¿ DULEX SURGICAL MESH FTL BRIDGER BIOMED, INC. -3031159 NA BRXI0017 00801741011856

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention