BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFIX PLUG

    MDR report key: 7287304 · Received February 21, 2018

    Report

    Report Number
    1213643-2018-00346
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    May 5, 2016
    Report Date
    February 12, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016615
    PMA / PMN Number
    K922916
    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 UNDERWENT AND ADDITIONAL SURGERY "TO REMOVE MESH AND RECURRENCE REPAIR." THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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: 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 6 YEARS 5 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND INFLAMMATION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AND INFLAMMATION AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4 (UDI NO.), 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. NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2009: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER (B)(4) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENCE REPAIR. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS AN ENLARGEMENT IN THE SUPERFICIAL INGUINAL RING AND THERE WAS A SUBSTANTIAL AMOUNT OF PREPERITONEAL FAT WHICH WAS PROTRUDING THROUGH IT. THE FLOOR OF THE INGUINAL CANAL WAS COMPLETELY WEAKENED IN ALL DIRECTIONS AND THE PELVIC FATTY CONTENTS WERE PROTRUDING OUTWARD. THEN A PERFIX PLUG (DEVICE #1) WAS INVERTED AND INSERTED INTO THE FLOOR OF THE CANAL AND THE EDGE OF THE PLUG WAS SUTURED TO THE ILIOPUBIC TRACT SUPERIORLY AND TO THE SHELVING EDGE OF THE INGUINAL LIGAMENT INFERIORLY. THE MESH OVERLAY WAS THEN WRAPPED AROUND THE SPERMATIC CORD AND THE TAILS OF THE OVERLAY WERE SUTURED TOGETHER.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PERFIX PLUG (DEVICE #1) AND IMPLANT OF ANOTHER PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS A FIRM AND INDURATED MASS AT THE EXTERNAL RING. THE OLD PERFIX PLUG (DEVICE #1) WAS REMOVED COMPLETELY. THE HERNIA SAC WAS ALSO IDENTIFIED AND ITS CONTENTS WERE INSPECTED, THEN AFTER SEPARATING THE SAC FROM THE CORD STRUCTURES THE CORD WAS LIGATED USING A SUTURE AND THE DISTAL END OF THE SAC WAS EXCISED. FOLLOWING THIS, AN EXTRA PERFIX PLUG (DEVICE #2) WAS PLACED IN THE FLOOR OF THE INGUINAL CANAL IN THE DIRECTION OF THE SAC AND THEN SECURED USING SUTURES. AN ONLAY MESH WAS SECURED TO THE FLOOR OF THE INGUINAL CANAL TO REINFORCE THE REPAIR AND THIS AGAIN WAS SECURED USING SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, HERNIA RECURRENCE, MESH MIGRATION, NERVE DAMAGE, PAIN AND SUFFERING AND ERECTILE DYSFUNCTION. IT IS ALSO ALLEGED THAT THE PATIENT HAD SUFFERED FROM PAIN AND DISCOMFORT, NUMBNESS IN THE TESTICLE AROUND THE SURGICAL SITE. ERECTILE DYSFUNCTION CAUSED FROM SECOND REPAIR OF THE DEFECTIVE BARD MESH.

    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 UNDERWENT AND ADDITIONAL SURGERY "TO REMOVE MESH AND RECURRENCE REPAIR." THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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. 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) 2009: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENCE REPAIR. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129799 PREFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTB0194 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Disability| R