BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7180147 · Received January 10, 2018

    Report

    Report Number
    1213643-2018-00053
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    April 9, 2010
    Report Date
    January 12, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016653
    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. IT IS UNCLEAR IF ONE OR BOTH DEVICES WERE EXPLANTED ON (B)(6) 2010. ADDENDUM: 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 1 YEAR POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH NERVE DAMAGE, HERNIA RECURRENCE, MESH DEFORMATION, FIBROSIS, INFLAMMATION AND PAIN THEREBY UNDERWENT REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST INFLAMMATION AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL PERFIX PLUG (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL PERFIX PLUG (DEVICE #1) AND AN EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #3). 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) 2008: THE PATIENT UNDERWENT A SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX, REFERENCE NUMBER 0112960 (DEVICE #1), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2009: THE PATIENT UNDERWENT A SECOND SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA, THIS MORE MEDIAL THAN THE FIRST. A BARD/DAVOL PERFIX, REFERENCE NUMBER (B)(4) (DEVICE #2), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2010: THE PATIENT UNDERWENT A REVISION SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE PERFIX DUE TO SEVERE PAIN AND NERVE ENTRAPMENT CAUSED BY THE PRODUCT'S FAILURE. AS ALLEGED, THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA WAS IDENTIFIED AND REDUCED THROUGH INTERNAL RING. A SMALL PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE EXTERNAL RING AND INTO INGUINAL CANAL AND SUTURED.¿. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE DIRECT INGUINAL HERNIA WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED.¿ (NOTE: THERE WAS NO VISUALIZATION OF PREVIOUS MESH). (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESHES AND IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ILIOINGUINAL AND ILIOHYPOGASTRIC NERVES WERE IDENTIFIED AND DIVIDED. THE ILIOINGUINAL NERVE HAD GONE INTO THE SCAR TISSUE. THE WADDED PIECE OF POLYPROPYLENE MESH (DEVICE #1 & DEVICE #2) WERE FREED AND REMOVED. A BARD FLAT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT GROIN PAIN WITH NERVE ENTRAPMENT SYNDROME THEREBY UNDERWENT LEFT GROIN EXPLORATION WITH ILIOINGUINAL NEURECTOMY. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LEFT GROIN PAIN DUE TO LEFT ILIOINGUINAL/ILIOHYPOGASTRIC NEURALGIA THEREBY UNDERWENT REPAIR. ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, MESH SHRINKAGE, NERVE DAMAGE, PAIN, HERNIA RECURRENCE AND ALSO ALLEGED THAT NEED FOR ADDITIONAL SURGERIES TO REMOVE OR REPAIR.

    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. IT IS UNCLEAR IF ONE OR BOTH DEVICES WERE EXPLANTED ON (B)(6) 2010. THIS EMDR REPRESENTS THE BARD DEVICE IMPLANTED ON (B)(6) 2009, DEVICE #2. AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE IMPLANTED ON (B)(6) 2008, DEVICE #1. 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) 2008: THE PATIENT UNDERWENT A SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX, REFERENCE NUMBER 0112960 (DEVICE #1), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009: THE PATIENT UNDERWENT A SECOND SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA, THIS MORE MEDIAL THAN THE FIRST. A BARD/DAVOL PERFIX, REFERENCE NUMBER 0112950 (DEVICE #2), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2010: THE PATIENT UNDERWENT A REVISION SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE PERFIX DUE TO SEVERE PAIN AND NERVE ENTRAPMENT CAUSED BY THE PRODUCT'S FAILURE. AS ALLEGED, THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED 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
    23611 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AQD214 00801741016653

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Disability| R