BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO MESH

    MDR report key: 7180199 · Received January 10, 2018

    Report

    Report Number
    1213643-2018-00054
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    March 14, 2016
    Report Date
    February 6, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016387
    PMA / PMN Number
    K100229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 MONTHS POST IMPLANT OF VENTRIO MESH, PATIENT WAS DIAGNOSED WITH MESH INFECTION, HEMATOMA, SEROMA, FIBROSIS, PURULENT DRAINAGE, ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) LISTS SEROMA, HEMATOMA AS POSSIBLE COMPLICATIONS. IN REGARD TO INFECTION, THE WARNINGS SECTION IN IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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

    IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2015, THE PATIENT HAD A BARD/DAVOL VENTRIO HERNIA PATCH, REFERENCE NUMBER (B)(4), LOT NUMBER HUWL1758 IMPLANTED TO REPAIR AN INCARCERATED VENTRAL HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRIO HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH. PER OPERATIVE NOTES, ¿OMENTUM WHICH WAS STUCK IN FEW PLACES WERE FREED AND PUSHED BACK INTO THE ABDOMINAL CAVITY. THE HERNIA SAC WAS EXCISED. THEN, A PREPERITONEAL SPACE WAS CREATED AND VENTRIO MESH WAS PLACED AND SECURED WITH STITCHES.¿ (B)(6) 2015 - PATIENT HAD POST OP VISITS. (B)(6) 2015 TO (B)(6) 2016 - PATIENT FREQUENTLY VISITED HOSPITAL FOR ABDOMINAL PAIN, SEROMA DRAINAGE, PURULENT DRAINAGE FROM INCISION, HOLE IS INFECTED AND STILL OPEN. PATIENT IS ON ANTIBIOTICS FOR INFECTION. (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR PAIN AND BLISTER FORMING. THE PHYSICAL EXAMINATION IN ABDOMEN CONFIRMS ERYTHEMATOUS AREA OVER THE INCISION AND THERE IS A CENTRAL AREA THAT CONTAINS FLUID. (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR OPEN WOUND IN MID ABDOMEN, WOUND HEMATOMA AND HAS BEEN TREATED WITH SEVERAL COURSES OF ANTIBIOTICS. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH. PER OPERATIVE NOTES, ¿THE BASE OF THE WOUND HAD A SMALL OPENING, AND THERE WAS CLOUDY FLUID ISSUING FROM THE OPENING. A DENSE FIBROTIC REACTION WAS ENCOUNTERED. SOME POLYPROPYLENE SUTURES WERE TRIMMED AND REMOVED. THE IMPLANTED MESH WAS IDENTIFIED, AND THE MESH CONTAINED A PSEUDOCAPSULE, ADJACENT TO THE PTFE SIDE AND THERE WAS CLOUDY FLUID, AND GRANULATION TISSUE IN THIS SITE. THE MESH WAS ABLE TO BE REMOVED INTACT.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, INFECTION, MESH SHRINKAGE, NERVE DAMAGE, PAIN, SEROMA, HERNIA RECURRENCE AND EMOTIONAL INJURIES. IT WAS ALSO ALLEGED THAT THE PATIENT HAD ADDITIONAL SURGERY TO REPAIR HEMIA AND REMOVE THE MESH; PERMANENT AND SEVERE SCARRING AND DISFIGUREMENT.

    Additional Manufacturer Narrative · 1

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE LIMITED INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD 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 BARD. NOT RETURNED.

    Description of Event or Problem · 1

    IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2015, THE PATIENT HAD A BARD/DAVOL VENTRIO HERNIA PATCH, REFERENCE NUMBER 0010211, LOT NUMBER HUWL1758 IMPLANTED TO REPAIR AN INCARCERATED VENTRAL HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRIO HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23651 VENTRIO MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWL1758 00801741016387

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Disability| R