BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 7160218 · Received January 3, 2018

    Report

    Report Number
    1213643-2018-00007
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 17, 2012
    Report Date
    January 23, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016493
    PMA / PMN Number
    PREAMENDMENT
    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 EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 2 YEARS 6 MONTHS POST IMPLANT OF BARD FLAT MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ABDOMINAL PAIN THEREBY UNDERWENT ADDITIONAL SURGERY. 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) 2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A FEMORAL HERNIA. A BARD/DAVOL MARLEX, REFERENCE NUMBER 0112640, LOT NUMBER HUTG0998 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE REPAIR OF THE MESH. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A FEMORAL HERNIA SAC PROTRUDING THROUGH THE FEMORAL CANAL AND THE SAC WAS REDUCED BACK INTO THE PERITONEAL CAVITY. A PIECE OF BARD FLAT MESH (DEVICE #1) WAS THEN PLACED INTO THE HERNIA DEFECT WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD KUGEL HERNIA PATCH (DEVICE #2). PER OPERATIVE NOTES, ¿AN INDIRECT HERNIA WAS FOUND, PRIOR INGUINAL HERNIA PLUG MESH (DEVICE #1) WAS IDENTIFIED, AND THE DEFECT WAS LATERAL. A SMALL OVAL SIZED BARD KUGEL HERNIA PATCH (DEVICE #2) WAS PLACED INTO THE POSITION WITH SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTIONS, PAIN AND EMOTIONAL INJURIES. IT WAS ALSO ALLEGED THAT THERE WAS TWO HOLES IN THE MESH IN WHICH 1 WAS REPAIRED AND 1 WAS NOT REPAIRED, LOSS OF VOLUME IN TESTICLES.

    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. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A FEMORAL HERNIA. A BARD/DAVOL MARLEX, REFERENCE NUMBER 0112640, LOT NUMBER HUTG0998 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE REPAIR OF THE MESH. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6551 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTG0998 00801741016493

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Disability| R