BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7242397 · Received February 5, 2018

    Report

    Report Number
    1213643-2018-00190
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    June 11, 2015
    Report Date
    July 3, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031472
    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. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORD REVIEW, ABOUT 1 YEARS 1 MONTH POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH ADHESIONS, FIBROSIS, HERNIA RECURRENCE AND MATERIAL DEFORMATION THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. PER OP NOTES, "OMENTUM WAS FREED CIRCUMFERENTIALLY, DISSECTED CONTRACTED PIECE OF MESH FOUND ADHERENT TO OMENTUM AND PARTIALLY INSIDE THE SAC". THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESION AS A POSSIBLE COMPLICATION. UPDATED FIELDS. CORRECTED FIELD: H4 (MANUFACTURING DATE) NOTE: SECTION A THROUGH F - 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. H3 OTHER TEXT : NOT RETURNED

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950007 , LOT NUMBER HUYB1017 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE BARD/DAVOL VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. 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) 2014 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WHICH ADHERENT TO THE LOWER UMBILICUS WAS DISSECTED. SOME FATTY ADHESIONS NOTED IN THE POSTERIOR FASCIA WERE REMOVED. THEN, A VENTRALEX ST MESH WAS PLACED UNDERNEATH THE PERITONEUM AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT EPIGASTRIC VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE EXPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿SOME OMENTAL ADHESIONS NOTED IN THE LEFT SIDE OF THE MIDLINE WERE REDUCED. HERNIA DEFECT WAS IDENTIFIED AS NOT REDUCIBLE. OMENTUM WAS FREED CIRCUMFERENTIALLY, DISSECTED CONTRACTED PIECE OF MESH FOUND ADHERENT TO OMENTUM AND PARTIALLY INSIDE THE SAC. DURING FASCIAL DEFECT CLOSURE, NEEDLE BROKE IN HALF DUE TO THE PRESENCE OF FIBROTIC AND ADHERENT PIECE OF MESH THAT WAS EXCISED. A TRIMMED SYNTHETIC MESH WAS INSERTED INTO THE PERITONEAL CAVITY TO COVER THE FASCIAL DEFECT AND TACKED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD NAUSEA, PAIN, ADHESIONS, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

    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. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950007, LOT NUMBER HUYB1017 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE BARD/DAVOL VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. 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
    84489 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYB1017 00801741031472

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Disability| R