BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7266108 · Received February 13, 2018

    Report

    Report Number
    1213643-2018-00261
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    April 8, 2016
    Report Date
    September 12, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH". THE DESCRIPTION DOES NOT CLEARLY DEFINE 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. ADDITIONALLY, THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR REASON FOR EXPLANT OF DEVICE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. 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 INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 9 MONTHS POST IMPLANT OF VENTRALEX ST, PATIENT WAS DIAGNOSED WITH ADHESIONS AND HERNIA RECURRENCE THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESION AS A POSSIBLE COMPLICATION. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRALEX ST (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE PHASIX 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. H3 OTHER TEXT: NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A SUPRAUMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER (B)(4) AND LOT NUMBER HUZC1594 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH." AS REPORTED BY THE ATTORNEY, THE VENTRALEX ST HERNIA PATCH USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC CONTAINING PREPERITONEAL FAT DUE TO OBESITY WAS EXCISED. THE UMBILICUS HAD A SMALL HERNIA THAT WAS CONNECTED TO OTHER HERNIA ABOVE UMBILICUS, MAKING THIS A VENTRAL HERNIA REPAIR. A VENTRALEX ST WAS THEN PLACED AS AN UNDERLAY PATCH UNDER THE FASCIA WITH SOME OMENTUM BEHIND THE MESH AND SUTURED THROUGH THE MARLEX SIDE OF THE MESH.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST (DEVICE #1) AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LYSIS OF SOME ADHESIONS OFF THE OLD MESH (DEVICE #1) WAS PERFORMED AND EXCISED THE MESH COMPLETELY. THE HERNIA DEFECT WAS IDENTIFIED AND DID A COMPONENT SEPARATION. A PHASIX MESH (DEVICE #2) WAS THEN TRIMMED, PLACED IN THE RETRORECTUS SPACE AND SUTURED.¿ (B)(6) 2016 - PATIENT UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS. PER OPERATIVE NOTES, ¿SOME SUTURES WERE REMOVED IN THE SUBCUTANEOUS AND THE ABSCESS POCKET WAS ENTERED. THE WOUND WAS COPIOUSLY IRRIGATED. THE ABDOMINAL WALL WAS INTACT AND NO MESH WAS PALPATED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, BOWEL OBSTRUCTION, HERNIA RECURRENCE, INFECTION AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE MESH AND REPAIR THE HERNIA AND TO TREAT FOR INFECTION. ALSO HAD PERMANENT AND SEVERE SCARRING AND DISFIGUREMENT.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH". THE DESCRIPTION DOES NOT CLEARLY DEFINE 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. ADDITIONALLY, THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR REASON FOR EXPLANT OF DEVICE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR 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

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A SUPRAUMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009 AND LOT NUMBER HUZC1594 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH." AS REPORTED BY THE ATTORNEY, THE VENTRALEX ST HERNIA PATCH USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109392 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZC1594 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Disability| R