BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7213908 · Received January 23, 2018

    Report

    Report Number
    1213643-2018-00111
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    April 18, 2014
    Report Date
    February 20, 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

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISK OF SURGERY AND ARE LISTED IN THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 6 MONTHS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH ADHESIONS, HERNIA RECURRENCE AND PAIN THEREBY UNDERWENT HERNIA REPAIR. 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: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH, REFERENCE NUMBER: (B)(4), LOT NUMBER: HUXF1771 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT VENTRAL INCISIONAL HERNIA AND REMOVE EXTENSIVE ADHESIONS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿HERNIA SAC WAS IDENTIFIED AND OPENED. A LARGE VENTRALEX ST MESH WAS PLACED INTRAABDOMINALLY AND SUTURED." ON (B)(6) 2014: PATIENT VISITED HOSPITAL FOR RECURRENT INCISIONAL HERNIA AND PAIN. ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BIOLOGIC MESH. PER OPERATIVE NOTES, ¿LYSIS OF ADHESION WAS PERFORMED. SEVERAL LOOPS OF SMALL BOWEL WERE DIVIDED FROM ADHERENT TISSUE TO REDUCE THEM FROM HERNIA DEFECT. SINGLE SMALL BOWEL SEROSAL TEAR WAS REPAIRED WITH SUTURE. A PIECE OF BIOLOGIC MESH WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED." (NOTE: THERE IS NO VISUALIZATION OF VENTRALEX ST IN OPERATIVE NOTES). ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, INFECTIONS, HERNIA RECURRENCE AND EMOTIONAL INJURY.

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISK OF SURGERY AND ARE LISTED IN THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. 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) 2013: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH, REFERENCE NUMBER 5950009, LOT NUMBER HUXF1771 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT VENTRAL INCISIONAL HERNIA AND REMOVE EXTENSIVE ADHESIONS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56858 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXF1771 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Disability| R