BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH ¿ VENTRALEX

    MDR report key: 21908081 · Received April 25, 2025

    Report

    Report Number
    1213643-2025-090172
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    July 5, 2019
    Report Date
    April 25, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741016486
    PMA / PMN Number
    K132441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 7 MONTHS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH INFECTION AND ADHESIONS THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS INFECTION AND ADHESIONS AS POSSIBLE COMPLICATION(S). IN REGARDS TO INFECTION THE WARNING SECTION OF IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE PATCH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MESH." NOTE, THE MANUFACTURING DATE (15-FEB-2009) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE MESH ¿ VENTRALEX (DEVICE #3). AN ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE MESH ¿ VENTRALEX (DEVICE #1) AND VENTRIO 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 INFORMATION PROVIDED: ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED FREE FROM THE UMBILICAL REGION. THEN A VENTRALEX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED BY SUTURES.¿ ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) WAS IDENTIFIED IN GOOD POSITION, JUST RIGHT TO THIS RE-HERNIA IS NOTED. A VENTRIO MESH (DEVICE #2) WAS PLACED INTO ABDOMINAL CAVITY AND SUTURED. ON (B)96) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #3) AND EXPLANT OF VENTRALEX MESH (DEVICE #1) AND VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) WAS REMOVED AS IT FOUND TO BE TOTALLY UNATTACHED TO THE LEFT SIDE OF THE RECTUS AND THE ANOTHER PREVIOUSLY PLACED VENTRIO MESH (DEVICE #2) WAS UNINCORPORATED AND ONE AREA THERE WAS SOME BUCKLING OF THE MESH ALLOWING TUNNELLING FROM AN AREA WHERE THE FIXATION TACKS WERE LOOSE. ALL ADHESIONS WERE TAKEN DOWN. A LARGE VENTRALEX MESH (DEVICE #3) WAS PLACED AND SUTURED. ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH INFECTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF ALLOMAX (DEVICE #4) AND EXPLANT OF VENTRALEX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THE VENTRALEX MESH (DEVICE #3) WAS DISSECTED FREE FROM THE UNDERSIDE OF THE FASCIA AND REMOVED. ADHESIONS WERE TAKEN DOWN AROUND THE HERNIA AND ALLOMAX MESH (DEVICE #4) WAS PLACED AND SECURED BY SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESION, INFECTION, PAIN, HERNIA RECURRENCE, PAIN, MESH MIGRATION AND MESH SHRINKAGE. IT IS ALSO ALLEGED THAT THE FIRST PLACED MESH WAS COMPLETELY DETACHED ON ONE SIDE RESULTING IN RECURRENT HERNIA, SECOND PLACED MESH WAS COMPLETELY UNINCORPORATED ALLOWING TUNNELING OF OMENTAL FAT UP INTO THE DEFECT AND RESULTING IN A HERNIA RECURRENCE, BUCKLING OF MESH ALLOWING THE LACKS TO COME LOOSE, WOUND VAC PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502166 MESH ¿ VENTRALEX SUGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUTB1468 00801741016486

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| S