BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 7210211 · Received January 22, 2018

    Report

    Report Number
    1213643-2018-00097
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    January 28, 2014
    Report Date
    March 7, 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

    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 INCLUDING THE ALLEGED "INCARCERATED RECURRENT INCISIONAL HERNIA." MEDICAL RECORDS WERE NOT PROVIDED; HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. ADDENDUM #1: THIS IS AN ADDENDUM TO THE INITIAL EMDR TO DOCUMENT A CORRECTION TO G4. THAT FIELD WAS INITIALLY INADVERTENTLY LEFT BLANK. THE FIELD SHOULD HAVE READ 12/30/2017 AS THAT WAS OUR INITIAL DATE OF AWARENESS FOR THIS EVENT. ADDENDUM #2: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 1 YEAR 5 MONTHS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH OBSTRUCTION, PAIN, SWELLING, ERYTHEMA, HERNIA RECURRENCE, ADHESIONS THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE LISTS ADHESIONS, PAIN AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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. NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX HERNIA PATCH, REFERENCE NUMBER (B)(4), LOT NUMBER HUVA0590 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR INCARCERATED RECURRENT INCISIONAL HERNIA. 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 HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE SAC IS REMOVED. A VENTRALEX MESH (DEVICE #1) WAS SECURED UNDERNEATH THE FASCIA AND PERITONEUM WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA WITH INFARCTION OF OMENTUM, PAIN, SWELLING, ERYTHEMA ALL CONSISTENT WITH SIGNS OF STRANGULATION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF OLD MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS TWO PIECES OF OMENTUM FORCED UP WITHIN THE DEFECT OF HERNIA SAC. ONE OF THOSE WAS INFARCTED OMENTUM AND NO BOWEL INVOLVED. THE FASCIAL DEFECT WAS ADJACENT AND DIRECTLY TO THE PREVIOUS REPAIR. UNTWISTED THE OMENTUM THAT WAS TWISTED IN AND THROUGH ITSELF. THE DARK PRE-NECROTIC PORTIONS OF THE OMENTUM WERE REMOVED AND THE HERNIA SAC WAS RESECTED. THIS EXPOSED THE INFERIOR VENTRALEX MESH THAT WAS IN THE APPROPRIATE POSITION AND REMOVED IT (DEVICE #1) FROM ITS ADHESIONS TO THE POSTERIOR RECTUS SHEATH AND LINEA ALBA. THE SUTURES USED TO SUTURE IT IN PLACE WERE ALSO REMOVED AND DID NOTE THE GRANULATION TISSUES. AN ALLOMAX SURGICAL GRAFT (DEVICE #2) WAS PLACED WITH SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE, MESH EXCISION SURGERY 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 INCLUDING THE ALLEGED "INCARCERATED RECURRENT INCISIONAL HERNIA." MEDICAL RECORDS WERE NOT PROVIDED; HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. 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.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE INITIAL EMDR TO DOCUMENT A CORRECTION TO DATE REC¿D BY MFR. THE FIELD SHOULD HAVE READ 12/30/2017 AS THAT WAS OUR INITIAL DATE OF AWARENESS FOR THIS EVENT. CORRECTED FIELDS: DATE REC¿D BY MFR.

    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 HUVA0590 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR INCARCERATED RECURRENT INCISIONAL HERNIA. 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 HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53722 MESH - VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVA0590 00801741000355

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Disability| R