BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONIX

    MDR report key: 7153035 · Received December 28, 2017

    Report

    Report Number
    1213643-2017-01129
    Event Type
    Injury
    Date Received
    December 28, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BRIDGER BIOMED, INC.
    Product Code
    FTL
    UDI-DI
    00801741011832
    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 WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS NO SPECIFIC DEVICE FAILURE MODE OR PATIENT INJURY WAS ALLEGED. 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. 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 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) 2004 - THE PATIENT WAS DIAGNOSED WITH VAGINAL WALL PROLAPSE WITH RECTOCELE AND ENTEROCELE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD DAVOL RECONIX MESH, VAGINAL POSTERIOR REPAIR AND ENTEROCELE REPAIR. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED "RECURRENCE OF ORIGINAL PROBLEM, SEVERE LOWER ABDOMINAL PAIN AND BOWEL PROBLEMS." IT IS ALLEGED THE DOCTOR TREATED THE PATIENT FOR PAIN AND REFERRED HER TO A PAIN SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932685 RECONIX SURGICAL MESH FTL BRIDGER BIOMED, INC. 0114510 41DNBR28 00801741011832

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention