BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 23775511 · Received December 11, 2025

    Report

    Report Number
    1213643-2025-01181
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    October 22, 2019
    Report Date
    December 8, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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-DEC-2018) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE VENTRALEX ST MESH (DEVICE 3). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE VENTRIO ST MESH (DEVICE 1), VENTRIO ST MESH (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 INFORMED PROVIDED: 08-APR-2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO ST MESH (DEVICE 1) WAS PLACED IN THE PERIFASCIAL REGION AND WAS SUTURED IN PLACED WITH SEVERAL SURGILON SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN ELLIPTICAL SKIN INCISION WAS MADE AROUND THE PREVIOUS SCAR AND UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO ST MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿LINEAR INCISION WAS MADE. THE HERNIA SAC WAS DISSECTED OUT. LYSIS OF ADHESION WAS PERFORMED. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ADHESION THEREBY UNDERWENT REPAIR WITH LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED MESH WAS WELL INCORPORATED BUT HEAVILY ADHERENT TO THE SMALL BOWEL. LYSIS OF ADHESION WAS PERFORMED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2771495 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUCZ0770 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention