BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3D MAX MESH

    MDR report key: 3030621 · Received March 22, 2013

    Report

    Report Number
    1213643-2013-00119
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    April 27, 2012
    Report Date
    June 18, 2015
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K953577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY'S REPORT ALLEGES THAT THE PATIENT UNDERWENT REPAIR OF A LEFT INGUINAL AND UMBILICAL HERNIA AND DURING THIS SURGERY A BARD 3DMAX MESH WAS PLACED. THE REPORT FURTHER ALLEGES THAT ONE MONTH LATER THE PATIENT PRESENTED WITH CHRONIC PAIN IN HIS RIGHT TESTICLE AND FOR THE NEXT TWO YEARS HE CONTINUED TO EXPERIENCE PROBLEMS WITH HIS RIGHT SIDE SUBSEQUENTLY, UNDERGOING A RIGHT ORCHIECTOMY. ALLEGEDLY THREE YEARS LATER HE PRESENTED WITH GROIN PAIN AND UNDERWENT RIGHT INGUINAL EXPLORATION, DURING THE SURGERY EXCISION OF PREPERITONEAL MESH WAS NOTED. IT IS UNCLEAR IF THE ALLEGED EXCISED MESH WAS THE 3DMAX MESH AS IT WAS ALLEGED THAT THE MESH WAS PLACED IN REPAIR OF A LEFT INGUINAL HERNIA AND THE ALLEGED PATIENT'S EXPERIENCES ARE ALL IN RELATION TO THE RIGHT SIDE. IT IS POSSIBLE THAT THE EXCISION OF THE MESH WAS INCIDENTAL DUE TO THE COMPLEX NATURE OF THE SURGERY. AT THIS TIME NO CONNECTION CAN BE MADE BETWEEN THE DAVOL PRODUCT IN QUESTION AND THE EVENTS OUTLINED IN THE ATTORNEY'S REPORT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT WAS TREATED FOR INFECTION AND INFLAMMATION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE EVENTS LISTED IN THE IFU. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." MEDICAL RECORDS/LOT NUMBER HAVE NOT BEEN PROVIDED, WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PATIENT, EVENT, AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6 )2006 - PATIENT PRESENTED FOR LAPAROSCOPIC LEFT INGUINAL HERNIA, UMBILICAL HERNIA REPAIR, IMPLANTING THE PATIENT WITH A BARD 3D MAX. ON (B)(6) 2007 - PATIENT PRESENT WITH CHRONIC PAIN IN HIS RIGHT TESTICLE. THE MD OBSERVED MULTIPLE CYSTIC STRUCTURES IN THE RIGHT EPIDIDYMIS, CONSISTENT WITH A SPERMATOCELE OR MULTIPLE EPIDIDYMIS CYSTS. ON (B)(6) 2007 - PATIENT PRESENTED WITH CHRONIC RIGHT EPIDIDYMITIS. ON (B)(6) 2007 - PATIENT PRESENTED FOR REMOVAL OF THE EPIDIDYMIS, EXCISION OF SPERMATOCELE AND EXCISION OF HYDROCELE. ON (B)(6) 2008 - PATIENT PRESENTED TO THE MD WITH PAIN IN HIS LEGS, RIGHT GROIN AND SCROTUM. UPON EXAMINATION, THE MD DISCOVERED MORE CYSTIC FORMATIONS IN IS RIGHT SCROTUM. AN ORCHIECTOMY WAS RECOMMENDED. ON (B)(6) 2008 - PATIENT PRESENTED FOR A RIGHT ORCHIECTOMY. FLUID AND LESIONS WERE FOUND IN HIS SCROTUM. ON (B)(6) 2012 - PATIENT PRESENTED PAIN IN HIS GROIN. HE UNDERWENT A RIGHT INGUINAL EXPLORATION, TRIPLE NERVE NEURECTOMY, EXCISION OF PREPERITONEAL MESH WITH EXTENSIVE RESECTION OF SURROUNDING INFLAMMATORY TISSUE, AND RIGHT INGUINAL FLOOR AND LOWER RIGHT ABDOMINAL WALL RECONSTRUCTION WITH IMPLANTATION OF NON-BARD BIOLOGIC MESH WITH ASSOCIATED SUPERIOR MYOFASCIAL FLAP ADVANCEMENT OF THE TRANSVERSE ABDOMINUS, INTERNAL OBLIQUE, AND RECTUS ABDOMINUS. THE ATTORNEY'S REPORT ALLEGES DISABILITY, INFECTION, PAIN, ADDITIONAL SURGERY, DEFECTIVE MESH, INFLAMMATION, EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119970 3D MAX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HQD035

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability