BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7268155 · Received February 13, 2018

    Report

    Report Number
    1213643-2018-00269
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    December 21, 2016
    Report Date
    August 1, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    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 AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG FAILED AND TO REMOVE THE PERFIX PLUG." MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME, 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. 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 1 YEAR 4 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH ADHESIONS, SCAR TISSUE AND PAIN THEREBY UNDERWENT REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESIONS AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112780, LOT NUMBER HUYD0166 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG 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: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG. PER OPERATIVE NOTES, ¿THE HERNIA WAS REDUCED, AND A LARGE PERFIX PLUG WAS PLACED INTO THE DEFECT AND SUTURED CIRCUMFERENTIALLY. A PRE-CUT PERFIX PATCH WAS NOW PLACED OVER THE PLUG, AND IT WAS SUTURED IN PLACE.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT ORCHIALGIA, AND GROIN PAIN THEREBY UNDERWENT REMOVAL OF MESH. PER OPERATIVE NOTES, ¿THERE IS FIBROUS ADHESION OVERLYING THE EXTERNAL OBLIQUE FASCIA FUSING IT TO THE SPERMATIC CORD AS WELL AS THE SYNTHETIC MESH. SCAR TISSUE WAS CAREFULLY INCISED EXPOSING THE SPERMATIC CORD. BLUNT AND SHARP DISSECTION ULTIMATELY FREED THE CORD FROM THE MESH FROM THE LEVEL OF THE FORMER EXTERNAL RING INFERIORLY.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, LOSS OF TESTICLES, PAIN AND EMOTIONAL INJURIES.

    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 AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG FAILED AND TO REMOVE THE PERFIX PLUG." MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME, 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. 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) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112780, LOT NUMBER HUYD0166 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE PERFIX PLUG 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
    112234 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYD0166

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Disability| R