BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7197044 · Received January 16, 2018

    Report

    Report Number
    1213643-2018-00073
    Event Type
    Injury
    Date Received
    January 16, 2018
    Report Date
    February 27, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016486
    PMA / PMN Number
    K021736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE, "PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE RECURRENT INGUINAL HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT OF ONE OR BOTH IMPLANTS, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. 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. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ORIGINAL ALLEGATION AND THE MEDICAL RECORDS PROVIDED TO DATE, THERE IS NO INDICATION OF AN ADVERSE EVENT OR MEDICAL/SURGICAL INTERVENTION ASSOCIATED TO THE VENTRALEX MESH. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR IS SUBMITTED TO REPRESENTS MESH ¿ VENTRALEX (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT PERFIX PLUG (DEVICE #1). 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) 2008: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER (B)(4) LOT NUMBER HURG0939 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ADDITIONALLY, A BARD/DAVOL VENTRALEX, REFERENCE NUMBER (B)(4) LOT NUMBER HUSB0243 WAS IMPLANTED TO REPAIR AN UMBILICAL HERNIA DEFECT. (B)(4) 2011: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT INGUINAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE DEFECTIVE DEFENDANTS' MESH PRODUCTS. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(4) 2008 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1) AND VENTRALEX MESH (DEVICE #2) RESPECTIVELY. PER OPERATIVE NOTES, ¿THERE WAS NOTED TO BE A LARGE DIRECT INGUINAL HERNIA AND A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED IN THE INGUINAL FLOOR SECURED IT TO THE SHELVING EDGE OF THE INGUINAL LIGAMENT INFERIORLY. THE REST OF THE REPAIR WAS DONE WITH A LARGE PIECE OF SYNTHETIC MESH. A VENTRALEX MESH (DEVICE #2) WAS THEN PLACED IN THE UMBILICAL HERNIA DEFECT AND FLATTENED AGAINST THE ABDOMINAL WALL WITH THE ROUGH SIDE OF THE MESH FACING THE ABDOMINAL WALL, THEN GORE-TEX SIDE OF THE MESH FACING TOWARDS THE ABDOMINAL CONTENTS AND WAS SECURED WITH SUTURES. A PORTION OF ILIOINGUINAL NERVE WAS EXCISED.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC PELVIC AND UTEROVAGINAL PROLAPSE, CYSTOCELE, RECTOCELE THEREBY UNDERWENT TRANSVAGINAL HYSTERECTOMY, SACROSPINOUS LIGAMENT VAGINAL VAULT SUSPENSION, ANTERIOR COLPORRHAPHY WITH DERMAL GRAFT, POSTERIOR COLPORRHAPHY WITH DERMAL GRAFT AND ENTEROCELE REPAIR. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND RIGHT-SIDED ABDOMINAL WALL DIASTASIS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE #3 & #4). PER OPERATIVE NOTES, ¿REDUCED AN INDIRECT INGUINAL HERNIA. THEN PLACED A PIECE OF 3DMAX MESH (DEVICE #3) MEDIALLY JUST ABOVE THE COOPER¿S LIGAMENT, LATERALLY TO ILIOPUBIC TRACT AND SUPERIORLY TO ABDOMINAL WALL MUSCULATURE. THERE WAS STILL NOT ENOUGH OVERLAP SUPERIORLY BECAUSE OF THE STRESSED-OUT NATURE OF THE ABDOMINAL WALL AND THE DIASTASIS THEREFORE ONE MORE PIECE OF 3DMAX MESH (DEVICE #4) WAS PLACED SUPERIOR TO THE PREVIOUS REPAIR AND TACKED IT IN A SIMILAR MANNER.¿ (NOTE, THERE WAS NO MENTION/VISUALIZATION OF OLD MESHES (DEVICE #1 & #2) DURING THE PROCEDURE). ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, NERVE DAMAGE, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE, "PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE RECURRENT INGUINAL HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT OF ONE OR BOTH IMPLANTS, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. 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. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALEX, DEVICE #2, IMPLANTED FOR REPAIR OF AN UMBILICAL HERNIA. AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL PERFIX PLUG, DEVICE #1, IMPLANTED FOR REPAIR OF AN INGUINAL HERNIA. 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) 2008: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER HURG0939 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ADDITIONALLY, A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010303, LOT NUMBER HUSB0243 WAS IMPLANTED TO REPAIR AN UMBILICAL HERNIA DEFECT. ON (B)(6) 2011: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RECURRENT INGUINAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE DEFECTIVE DEFENDANTS' MESH PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37931 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSB0243 00801741016486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability| R