BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7345708 · Received March 16, 2018

    Report

    Report Number
    1213643-2018-00627
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 20, 2015
    Report Date
    November 25, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016479
    PMA / PMN Number
    K021736
    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 UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE #5 USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, 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 THE COMPLAINANT E-MAIL ADDRESS AND 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 2 YEARS 10 MONTHS POST IMPLANT OF MESH ¿ VENTRALEX, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS AND ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. PER OPERATIVE NOTES, "THE MESH (DEVICE #1 & #5) OVER THE UMBILICAL AREA FOLDED UP WAS REMOVED." THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE, ADHESIONS AND PAIN AS A POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, B2, B3 (DATE OF EVENT), B4, B5, B7, D4 (UDI NO), D.6B (DATE OF EXPLANT), E1 (COMPLAINANT NAME), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELDS: E1 (COMPLAINANT E-MAIL ADDRESS), H4 (MANUFACTURING DATE) THIS SUPPLEMENTAL EMDR REPRESENTS THE MESH ¿ VENTRALEX (DEVICE #5). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE PERFIX PLUG LIGHT (DEVICE #2, #3 & #6) AND MESH ¿ VENTRALEX (DEVICE #1, & #4). 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 IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, HUVI0025 (DEVICE #1). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL "MARLEX" PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #2) AND A BARD/DAVOL PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUVJ0711 (DEVICE #4), AND A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUWA1805 (DEVICE #5). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX MEDIUM, REFERENCE NUMBER 0117160, LOT NUMBER HUUG1217 (DEVICE #6). AS REPORTED, THE ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED". ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, "THE SAC WAS DISSECTED FREE FROM THE MARGINS OF FASCIAL DEFECT. A CIRCULAR VENTRALEX PATCH WAS POSITIONED UNDERNEATH THE FASCIA AND SECURED WITH SUTURES." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG (DEVICE #2 & #3). PER OPERATIVE NOTES, "THE DIRECT SPACE DEFECT WAS PLACED WITH A PERFIX LIGHT PLUG (DEVICE #2) AND THE INGUINAL FLOOR WAS RECONSTRUCTED USING SUTURE AND INCORPORATING THE UNDERLYING PLUG. SIMILAR REPAIR WAS PERFORMED ON THE LEFT SIDE AND PERFIX PLUG (DEVICE #3) WAS USED." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH TWO VENTRAL HERNIAS THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF VENTRALEX PATCH (DEVICE #4 & #5). PER OPERATIVE NOTES, "A BULGING MASS WAS NOTED IN RIGHT LOWER QUADRANT AND INCISED DOWN TO THE ANTERIOR RECTUS SHEATH. A HERNIA DEFECT WAS NOTED BULGING THROUGH POSTERIOR SHEATH. A CIRCULAR VENTRALEX MESH (DEVICE #4) WAS PLACED AND SUTURED. A SUPRAUMBILICAL HERNIA WAS NOTED. THE DEFECT IN THE LINEA ALBA WAS REPAIRED USING A VENTRALEX PATCH (DEVICE #5) AND SUTURED." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH TWO VENTRAL HERNIAS THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF PER FIX LIGHT PLUG DEVICE ONLAY PATCH (DEVICE #6). PER OPERATIVE NOTES, "THE DEFECT WAS SEEN AND CARRIED DOWN TO THE RECTUS SHEATH. THE SHEATH WAS OPENED AND WEAKNESS ON BOTH SIDES WAS SEEN AND A MARLEX PATCH (DEVICE #6) WAS SUTURED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC HERNIA REPAIR WITH REMOVAL OF MESHES AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, "ADHESIONS ATTACHED AT THE BOTTOM OF UMBILICUS WITH OMENTUM WAS NOTED. THE MESH WAS FOLDED UP OVER THE OMENTUM. THE TWO MESHES SEEMED TO OVERLAP ONE ANOTHER. THE OMENTUM ATTACHED TO THE MESH WAS DETACHED. A PIECE OF OMENTUM WAS CREEPED OVER THE MESH INTO HER UMBILICUS WITH RECURRENT HERNIA. THE MESH WAS DISSECTED ON FREEING THIS MESH THE SECOND MESH WAS FREED. THE MESH (DEVICE #1 & #5) OVER THE UMBILICAL AREA FOLDED UP WAS REMOVED. THE AREA OF PAIN OVER THE RIGHT ABDOMEN WAS NOTED. THE MESH (DEVICE #4) WAS DETACHED AND REMOVED. THE MESH (DEVICE #6) WAS RETRIEVED. A SYNTHETIC MESH WAS PLACED AND SUTURED." ATTORNEY ALLEGED THAT THE PATIENT HAD ADHESIONS, MESH SHRINKAGE, HERNIA RECURRENCE AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT HAD REVISION SURGERY, SURGERY TO REMOVE MESH, MESH GOT BALLED /WADED UP AND CHRONIC ABDOMINAL PAIN.

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL DEVICE #5 USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, 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. THIS EMDR REPRESENTS DEVICE #5. FIVE ADDITIONAL EMDR WERE SUBMITTED TO REPRESENT THE REMAINING BARD DEVICES. 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 IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, HUVI0025 (DEVICE #1). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL "MARLEX" PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #2) AND A BARD/DAVOL PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUVJ0711 (DEVICE #4), AND A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUWA1805 (DEVICE #5). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX MEDIUM, REFERENCE NUMBER 0117160, LOT NUMBER HUUG1217 (DEVICE #6). AS REPORTED, THE ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188426 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWA1805 00801741016479

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Disability| R