BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 24483442 · Received March 2, 2026

    Report

    Report Number
    1213643-2026-00262
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 3, 2014
    Report Date
    February 18, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031472
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. NOTE, THE MANUFACTURING DATE (15-MAY-2013) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE VENTRALEX ST (DEVICE 3). ADDITIONAL SUPPLEMENTAL EMDR¿S WERE SUBMITTED TO REPRESENT THE VENTRALEX ST (DEVICE 1) AND VENTRALEX ST (DEVICE 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: (B)(6) 2012: PATIENT WAS DIAGNOSED WITH 2 VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, ¿PREVIOUS INCISION WAS REOPENED IN UMBILICUS. THE HERNIA SAC WAS OPENED AND ADHESIONS WERE TAKEN DOWN. THE DEFECT WAS REPAIRED WITH SUTURES. ANOTHER HERNIA DEFECT WAS NOTED ON LEFT LOWER QUADRANT. THE SAC WAS OPENED AND ADHESIONS WERE LYSED. A VENTRALEX ST (DEVICE 1) WAS PLACED ON LLQ AND SUTURED.¿ (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT TWO VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 2 AND 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND FREED BACK AT THE LEVEL OF FASCIA. EXCESS SAC WAS EXCISED. ADHESIONS OF BOTH PRIOR INCISION SITES WERE LYSED. BOTH DEFECTS WERE NOTED. TWO VENTRALEX ST (DEVICE 2 AND 3) NEAR UMBILICUS AND LLQ WERE PLACED ON BOTH DEFECTS INTRAPERITONEALLY AND SUTURED.¿ (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE VENTRAL INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE 1,2 AND 3) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿SIGNIFICANT ADHESIONS WERE NOTED IN ABDOMINAL WALL WAS LYSED. SWISS CHEESE RECURRENT HERNIAS WITH INCARCERATED OMENTUM WERE NOTED AND REDUCED. MULTIPLE LOOPS OF SMALL BOWEL WERE RELEASED. THE BOWEL WAS INGROWN INTO OLD MESH (DEVICE 1,2 AND 3). THE MESH NEAR THE UMBILICUS (DEVICE 2) WAS TRANSECTED. OLD LLQ DEFECT WAS NOTED AND REDUCED. ANOTHER MESHES (DEVICE 1 AND 3) WERE TRANSECTED. MULTIPLE DEFECTS WERE REDUCED. A LARGE SYNTHETIC MESH WAS PLACED AND SECURED USING SUTURES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545314 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUXE1303 00801741031472

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention