BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7309937 · Received March 2, 2018

    Report

    Report Number
    1213643-2018-00448
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    March 2, 2017
    Report Date
    October 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

    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 WAS ADMITTED TO THE HOSPITAL WITH A RECURRENCE OF HIS RIGHT INGUINAL HERNIA AND THAT THE "PATIENT SUFFERED FROM BOWEL OBSTRUCTION, BOWEL DAMAGE, PAIN, SWELLING AND SCARRING OF NERVE TISSUE." NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SPECIFIC DEVICE ISSUE HAS BEEN ALLEGED. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND RECURRENCE AND INFLAMMATION ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. 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 10 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH NERVE DAMAGE, OBSTRUCTION, HERNIA RECURRENCE, ABDOMINAL PAIN AND SCAR TISSUE THEREBY UNDERWENT REPAIR. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4 (UDI NO), E1, E3, G1, G3, G6, H2, H6, H10. 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 THE REPAIR OF A RIGHT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER HUYL0147 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A RECURRENCE OF HIS RIGHT INGUINAL HERNIA. AS REPORTED, THE PATIENT SUFFERED FROM BOWEL OBSTRUCTION, BOWEL DAMAGE, PAIN, SWELLING AND SCARRING OF NERVE TISSUE. AS ALLEGED, THE PATIENT HAD TO UNDERGO AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND THE EXTENT OF THE PATIENT'S COMPLICATIONS RENDERED REPAIR WITH ANOTHER MESH DEVICE UNFEASIBLE. 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. PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG. PER OPERATIVE NOTES, ¿A LIPOMA THAT COULD HAVE BEEN A SAC REMNANT WAS RESECTED. A GOLF BALL-SIZED HERNIA WAS NOTED. A PERFIX PLUG WAS PLACED AND SUTURED¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, SMALL BOWEL OBSTRUCTION AND RECURRENT INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT EXPLORATORY LAPAROSCOPY FOLLOWED BY OPEN REPAIR. PER OPERATIVE NOTES, ¿THE ABDOMEN WAS NOTED TO HAVE SOME MILDLY DILATED LOOPS OF BOWEL, IDENTIFIED WITH AN INDIRECT HERNIA. THE LOOP OF BOWEL WAS REDUCED AND THERE WERE SOME SEROSAL HEMORRHAGE AND MESENTERY. HERNIA SAC AND CORD STRUCTURES WERE IDENTIFIED FROM THE PREVIOUS INCISION AND DISSECTED HE CORD STRUCTURES OFF THE HERNIA SAC. TISSUE REPAIR OF THE INTERNAL OBLIQUE APONEUROSIS TO THE SHELVING EDGE TO CLOSE THE OBVIOUS LARGE HERNIA DEFECT WAS PERFORMED. THE PREVIOUS MESH PATCH WAS IDENTIFIED, THE ILIOINGUINAL NERVE WAS UNABLE TO IDENTIFIED AND PRESUMED TO BE SCARRED TO HIM HERNIA PATCH. THE FASCIA WAS CLOSED WITH SUTURES.¿ ATTORNEY ALLEGED THAT THE PATIENT HAD BOWEL OBSTRUCTION, NERVE DAMAGE, PAIN AND HERNIA RECURRENCE.

    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 WAS ADMITTED TO THE HOSPITAL WITH A RECURRENCE OF HIS RIGHT INGUINAL HERNIA AND THAT THE "PATIENT SUFFERED FROM BOWEL OBSTRUCTION, BOWEL DAMAGE, PAIN, SWELLING AND SCARRING OF NERVE TISSUE." NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO SPECIFIC DEVICE ISSUE HAS BEEN ALLEGED. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND RECURRENCE AND INFLAMMATION ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. 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 THE REPAIR OF A RIGHT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER HUYL0147 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A RECURRENCE OF HIS RIGHT INGUINAL HERNIA. AS REPORTED, THE PATIENT SUFFERED FROM BOWEL OBSTRUCTION, BOWEL DAMAGE, PAIN, SWELLING AND SCARRING OF NERVE TISSUE. AS ALLEGED, THE PATIENT HAD TO UNDERGO AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND THE EXTENT OF THE PATIENT'S COMPLICATIONS RENDERED REPAIR WITH ANOTHER MESH DEVICE UNFEASIBLE. 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
    153180 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYL0147 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| S| R