BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7159859 · Received January 3, 2018

    Report

    Report Number
    1213643-2017-01154
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 31, 2014
    Report Date
    January 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

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS NO SPECIFIC DEVICE FAILURE MODE WAS ALLEGED. BASED ON THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A RECURRENCE REPAIR, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, 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 MANUFACTURING REVIEW WAS PERFORMED WHICH FOUND NO ANOMALIES DURING THE MANUFACTURING PROCESS OF THE DEVICE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS FILE REPRESENTS THE PERFIX PLUG (DEVICE #2) IMPLANTED IN (B)(6) 2010. TWO ADDITIONAL EMDRS HAVE BEEN SUBMITTED FOR THE OTHER TWO PERFIX PLUGS (DEVICE #1 AND DEVICE #3). ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 YEARS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH ADHESIONS AND HERNIA RECURRENCE THEREBY UNDERWENT REPAIR PROCEDURE. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESIONS AS A POSSIBLE COMPLICATION. THIS SUPPLEMENTAL EMDR REPRESENTS PERFIX PLUG (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT PERFIX PLUGS (DEVICE #1 & #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 REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2010- THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA, TWO PERFIX PLUGS (DEVICE #1 AND DEVICE #2), REFERENCE NUMBERS (B)(4) AND LOT NUMBERS HUUG1052 AND HUUI2244 WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014 - THE PATIENT UNDERWENT A RECURRENCE REPAIR WITH ANOTHER PERFIX PLUG (DEVICE #3) PLACED, REFERENCE NUMBER (B)(4) AND LOT NUMBER HUYE1702. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PAIN AND WAS INJURED SEVERELY AND PERMANENTLY. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE RIGHT INGUINAL HERNIA WAS DONE FIRST AND A MODERATE SIZE DIRECT DEFECT WAS FOUND. AN EXTRA-LARGE MESH PLUG (DEVICE #1) WAS PLACED ON THE DEFECT. THEN A PATCH WAS PLACED OVER TOP AND SUTURED TO THE PERIOSTEUM OF THE PUBIC TUBERCLE MEDIALLY, TO THE SHELVING EDGE OF THE INGUINAL LIGAMENT INFERIORLY. THEN THE LEFT INGUINAL HERNIA WAS DONE THE SAME WAY AND THERE WAS A DIRECT DEFECT WHICH WAS SOMEWHAT SMALLER THAN THE RIGHT SIDE. A LARGE PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED IN THE SAME WAY. THERE WAS A DIME-SIZED FASCIAL DEFECT WITH SOME FATTY TISSUE. UMBILICUS WAS FREED UP OFF THE FASCIA.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE #3 & #4). PER OPERATIVE NOTES, ¿THE LEFT SIDE EXTERNAL OBLIQUE FASCIA WAS IDENTIFIED WHICH WAS ADHERENT DOWN TO THE MESH. THE PATIENT HAD FAT CONTAINING HERNIA BULGING THROUGH THE INTERNAL RING. TISSUES NEAR THE MESH WERE QUITE ADHERENT AND COULD NOT BE DISSECTED OUT, SO ANOTHER PERFIX PLUG (DEVICE #3) WAS PLACED INTO THE DEFECT AND SUTURED IT TO THE EDGE OF THE PREVIOUS MESH (DEVICE #2). THE RIGHT SIDE EXTERNAL OBLIQUE FASCIA WAS IDENTIFIED WITH A RECURRENT HERNIA DEFECT COMING THROUGH THE INTERNAL RING AND THE MESH PATCH. THIS WAS REDUCED BACK INTO THE ABDOMINAL CAVITY. ANOTHER PERFIX PLUG (DEVICE #4) WAS PLACED INTO THE DEFECT AND SUTURED IT TO THE PREVIOUS MESH RING (DEVICE #1).¿ ATTORNEY ALLEGES THAT THE PATIENT HAD HERNIA RECURRENCE, PAIN AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS NO SPECIFIC DEVICE FAILURE MODE WAS ALLEGED. BASED ON THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A RECURRENCE REPAIR, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, 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 MANUFACTURING REVIEW WAS PERFORMED WHICH FOUND NO ANOMALIES DURING THE MANUFACTURING PROCESS OF THE DEVICE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS FILE REPRESENTS THE PERFIX PLUG (DEVICE #2) IMPLANTED IN (B)(6) 2010. TWO ADDITIONAL EMDRS HAVE BEEN SUBMITTED FOR THE OTHER TWO PERFIX PLUGS (DEVICE #1 AND DEVICE #3). 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 TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA, TWO PERFIX PLUGS (DEVICE #1 AND DEVICE #2), REFERENCE NUMBERS 0112780 AND 0112970 AND LOT NUMBERS HUUG1052 AND HUUI2244 WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014 - THE PATIENT UNDERWENT A RECURRENCE REPAIR WITH ANOTHER PERFIX PLUG (DEVICE #3) PLACED, REFERENCE NUMBER 0112970 AND LOT NUMBER HUYE1702. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PAIN AND WAS INJURED SEVERELY AND PERMANENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4741 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 0112970 HUUI2244 00801741016677

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Disability| R