BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DULEX MESH

    MDR report key: 5761679 · Received June 30, 2016

    Report

    Report Number
    1213643-2016-00297
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    July 31, 2008
    Report Date
    June 6, 2016
    Manufacturer
    BRIDGER BIOMED, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2003 - PATIENT WAS PREVIOUSLY DIAGNOSED WITH STRESS URINARY INCONTINENCE AND VAGINAL PROLAPSE. THE PATIENT UNDERWENT A LAPAROSCOPIC SACROCOLPOPEXY WITH IMPLANT OF A BARD DULEX MESH AND A PUBOVAGINAL SLING USING A NON-BARD DAVOL DEVICE. ON (B)(6) 2008 - THE PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE AND COMPLETE PROLAPSE. THE PATIENT UNDERWENT A TWO PART PROCEDURE WHICH INCLUDED PLACEMENT OF A NON-BARD DAVOL TRANSOBTURATOR SLING, CYSTOSCOPY, PARAVAGINAL REPAIR, SACROSPINOUS LIGAMENT SUSPENSION WITH SUTURES, POSTERIOR AND ENTEROCELE REPAIR. THE OPERATIVE DETAILS PROVIDED DID NOT MENTION ANY INVOLVEMENT OR VISUALIZATION OF THE BARD DULEX MESH DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418153 DULEX MESH SURGICAL MESH FTL BRIDGER BIOMED, INC. 41DLBR04

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention