BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7302361 · Received February 28, 2018

    Report

    Report Number
    1213643-2018-00400
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    November 29, 2016
    Report Date
    October 23, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016677
    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/DAVOL PERFIX PLUG (DEVICE #2) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE OF RIGHT INGUINAL HERNIA. UPON EXAMINATION, "SLIGHT DISLODGEMENT OF THE MESH" WAS DISCOVERED AND THE PREVIOUS MESH WAS RE-SUTURED IN PLACE. NO MEDICAL RECORDS HAVE BEEN PROVIDED; HOWEVER, 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NO ALLEGATIONS HAVE BEEN ASSOCIATED WITH THE BARD/DAVOL PERFIX PLUG (DEVICE #1), LOT NUMBER HUZB1129, REFERENCE NUMBER (B)(4) NOR THE BARD/DAVOL PERFIX PLUG (DEVICE #3), LOT NUMBER HUX1739, REFERENCE NUMBER (B)(4). 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 7 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND PAIN THEREBY UNDERWENT REPAIR. UPDATED FIELDS: A2, 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. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL LARGE PERFIX PLUG (DEVICE #1), LOT NUMBER HUZB1129, REFERENCE NUMBER (B)(4). NO ALLEGATIONS OR ADVERSE EVENTS ARE ASSOCIATED WITH THIS DEVICE WHICH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA . A BARD/DAVOL LARGE PERFIX PLUG (DEVICE #2), REFERENCE NUMBER (B)(4), LOT NUMBER HUAN0133 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE OF RIGHT INGUINAL HERNIA. AS REPORTED, UPON EXAMINATION, "SLIGHT DISLODGEMENT OF THE MESH" WAS DISCOVERED AND THE PREVIOUS MESH WAS RE-SUTURED IN PLACE. AS REPORTED, A BARD/DAVOL SMALL PERFIX PLUG (DEVICE #3), LOT NUMBER HUX1739, REFERENCE NUMBER (B)(4) WAS IMPLANTED TO REPAIR THE RECURRENT HERNIA. NO ALLEGATIONS OR ADVERSE EVENTS ARE ASSOCIATED WITH THIS DEVICE. 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) 2016 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE INDIRECT SAC WAS REDUCED AND TWO EXTRA-LARGE PLUGS WERE PLACED TO BRIDGE THE DEFECT AND SUTURED. THERE WAS WEAKNESS IN THE INGUINAL FLOOR, FIXED BY PLACING MESH ON THE FLOOR AND SUTURED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿INDIRECT SAC WAS REDUCED. AN EXTRA-LARGE PLUG WAS PLACED IN THE DEEP RING AND SUTURED. THEN, THE INGUINAL FLOOR WAS REINFORCED WITH A PROLENE MESH AND SUTURED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS SEPARATED. IT APPEARED THAT THE INFERIOR EDGE OF THE MESH WAS DISLODGED THAT WAS RESUTURED." (B)(6) 2017 - PATIENT COMPLAINS OF RIGHT GROIN PAIN. ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED TREMENDOUS SUFFERING AND MENTAL ANGUISH THEREBY UNDERWENT ADDITIONAL INVASIVE PROCEDURES INCLUDING A MESH REVISION SURGERY AND HOSPITALIZATIONS.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD/DAVOL PERFIX PLUG (DEVICE #2) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE OF RIGHT INGUINAL HERNIA. UPON EXAMINATION, "SLIGHT DISLODGEMENT OF THE MESH" WAS DISCOVERED AND THE PREVIOUS MESH WAS RE-SUTURED IN PLACE. NO MEDICAL RECORDS HAVE BEEN PROVIDED; HOWEVER, 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NO ALLEGATIONS HAVE BEEN ASSOCIATED WITH THE BARD/DAVOL PERFIX PLUG (DEVICE #1), LOT NUMBER HUZB1129, REFERENCE NUMBER 0112970 NOR THE BARD/DAVOL PERFIX PLUG (DEVICE #3), LOT NUMBER HUX1739, REFERENCE NUMBER 0112950. 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) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL LARGE PERFIX PLUG (DEVICE #1), LOT NUMBER HUZB1129, REFERENCE NUMBER 0112970. NO ALLEGATIONS OR ADVERSE EVENTS ARE ASSOCIATED WITH THIS DEVICE WHICH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA . A BARD/DAVOL LARGE PERFIX PLUG (DEVICE #2), REFERENCE NUMBER 0112970, LOT NUMBER HUAN0133 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR RECURRENCE OF RIGHT INGUINAL HERNIA. AS REPORTED, UPON EXAMINATION, "SLIGHT DISLODGEMENT OF THE MESH" WAS DISCOVERED AND THE PREVIOUS MESH WAS RE-SUTURED IN PLACE. AS REPORTED, A BARD/DAVOL SMALL PERFIX PLUG (DEVICE #3), LOT NUMBER HUX1739, REFERENCE NUMBER 0112950 WAS IMPLANTED TO REPAIR THE RECURRENT HERNIA. NO ALLEGATIONS OR ADVERSE EVENTS ARE ASSOCIATED WITH THIS DEVICE. 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
    145561 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUAN0133 00801741016677

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Disability| R