BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONIX

    MDR report key: 5761684 · Received June 30, 2016

    Report

    Report Number
    1213643-2016-00300
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    May 14, 2009
    Report Date
    June 6, 2016
    Manufacturer
    BRIDGER BIOMED, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS WERE LIMITED TO THE PATIENT'S OPERATIVE REPORT AND IMPLANT TRACKING LOG ONLY. THE MEDICAL RECORDS INDICATE THE PATIENT EXPERIENCED ADHESIONS. ADHESIONS IS LISTED AS A POSSIBLE KNOWN ADVERSE REACTION IN THE INSTRUCTIONS-FOR-USE. WHILE AN EXPLANT DATE OF (B)(6) 2009 IS LISTED, THE OPERATIVE DETAILS FOR THIS PROCEDURE STATE "RIGHT IN THE PRESACRAL AREA A VERY HARD FOREIGN BODY PALPATED IN THE LUMEN OF THE MID RECTUM. IT WAS VERY DIFFICULT TO DETERMINE WHAT THAT WAS." BASED ON THE INFORMATION PROVIDED IT IS UNCLEAR AS TO WHAT WAS EXPLANTED DURING (B)(6) 2009 PROCEDURE. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR 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.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH A CYSTOCELE, PROLAPSE RECTUM AND UNDERWENT A RIPSTEIN REPAIR WITH IMPLANT OF A BARD RECONIX MESH, COLON RESECTION AND A CYSTOCELE REPAIR WITH IMPLANT OF A NON BARD DAVOL MONARC SUBFASCIAL MESH SLING. ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INTRALUMINAL RECTAL FOREIGN BODY CAUSING A STRICTURE AND INTRAABDOMINAL ADHESIONS. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, COLOSTOMY WITH REMOVAL OF RECTAL FOREIGN BODY, LYSIS OF ADHESIONS AND A COLONIC DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417204 RECONIX SURGICAL MESH FTL BRIDGER BIOMED, INC. 41COBR29

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention