BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7309849 · Received March 2, 2018

    Report

    Report Number
    1213643-2018-00447
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    March 20, 2016
    Report Date
    October 23, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K024008
    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 "SUFFERED FROM PAIN, NAUSEA, VOMITING, ADHESIONS AND SMALL BOWEL OBSTRUCTION" AND AS REPORTED THE SURGEON REMOVED THE MESH. NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED. ADHESIONS ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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 3 YEARS 4 MONTHS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH ADHESIONS AND BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4 (UDI NO), E1, E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELD: H4 (MANUFACTURING DATE) 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) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH, REFERENCE NUMBER 0010301, LOT NUMBER HUWG0585 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SUFFERED FROM PAIN, NAUSEA, VOMITING, ADHESIONS AND SMALL BOWEL OBSTRUCTION. AS REPORTED, THE SURGEON REMOVED THE MESH. AS ALLEGED, THE PATIENT WAS SEVERELY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH. PER OPERATIVE NOTES, "HERNIA SAC WAS EXCISED. A SMALL VENTRALEX MESH WAS THEN PLACED INTO THE ABDOMEN AND PULLED UP AGAINST THE ABDOMINAL WALL USING THE STRAPS. THE FASCIA OVERLYING THE MESH WAS THEN CLOSED WITH PROLENE SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND LYSIS OF ADHESIONS THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH. PER OPERATIVE NOTES, ¿APPEARING LOOP OF BOWEL IN THE LEFT MID ABDOMEN. REMOVED THE SMALL SUBFASCIAL PIECE OF MESH. SEGMENT OF SMALL BOWEL INVOLVED IN A CLOSED LOOP BOWEL OBSTRUCTION.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, PAIN AND EMOTIONAL INJURIES. IT WAS ALSO ALLEGED THAT THE PATIENT HAD NAUSEA, VOMITING, INFLAMED AND DILATED LOOP OF BOWEL, TWISTED LOOP OF BOWEL, CLOSED LOOP OBSTRUCTION AND DIGESTIVE ISSUES.

    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 "SUFFERED FROM PAIN, NAUSEA, VOMITING, ADHESIONS AND SMALL BOWEL OBSTRUCTION" AND AS REPORTED THE SURGEON REMOVED THE MESH. NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED. ADHESIONS ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS 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. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH, REFERENCE NUMBER 0010301, LOT NUMBER HUWG0585 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SUFFERED FROM PAIN, NAUSEA, VOMITING, ADHESIONS AND SMALL BOWEL OBSTRUCTION. AS REPORTED, THE SURGEON REMOVED THE MESH. AS ALLEGED, THE PATIENT WAS SEVERELY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152145 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWG0585 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| S| R