BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7242398 · Received February 5, 2018

    Report

    Report Number
    1213643-2018-00187
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    July 24, 2017
    Report Date
    June 17, 2024
    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

    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. H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE 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 7 YEARS 3 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, SCAR TISSUE AND EXTRUSION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. PER OP NOTES, ¿MASS JUST LATERAL TO THE INTERNAL RING FROM MESH THAT WAS SUSPICIOUS FOR A MESH PLUG THAT WAS BEING EXTRUDED.¿ REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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: DEVICE 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 RIGHT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER HUSB0291 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG ALLEGEDLY FAILED AND TO REMOVE THE PERFIX PLUG. 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) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF 3DMAX (DEVICE #1) AND OPEN RIGHT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿ON THE LEFT SIDE, A SMALL DEFECT WAS NOTED AND A 3DMAX MESH (DEVICE #1) WAS PLACED OVER THE DEFECT. ON THE RIGHT SIDE, A MASSIVE INDIRECT RIGHT HERNIA SAC WAS NOTED. THE HERNIA SAC WAS REMOVED AND PLACED A PERFIX PLUG (DEVICE #2) IN THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECTAL BLEEDING, RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF OLD MESH (PERFIX PLUG ¿ DEVICE #2). PER OPERATIVE NOTES, ¿IN THE RIGHT GROIN, THERE WAS SIGNIFICANT SCARRING FROM THE PREVIOUS RIGHT INGUINAL HERNIA REPAIR. THERE WAS A MASS JUST LATERAL TO THE INTERNAL RING FROM MESH THAT WAS SUSPICIOUS FOR A MESH PLUG THAT WAS BEING EXTRUDED AND THIS WAS COMPLETELY EXCISED (DEVICE #2). THE PATIENT WAS NOTED TO HAVE SOME PATCHY LENGTHS AT THE INTERNAL RING WHERE THE MESH WAS REMOVED SUSPICIOUS FOR AN INDIRECT HERNIA. A PIECE OF BARD SOFT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD HERNIA RECURRENCE, PAIN, RECTAL BLEEDING, MESH MIGRATION 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. 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. 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 RIGHT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER (B)(4) , LOT NUMBER HUSB0291 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG ALLEGEDLY FAILED AND TO REMOVE THE PERFIX PLUG. 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
    84493 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSB0291 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Disability| R