BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2191728 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02713
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-02593. THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SLING SYSTEM WAS USED DURING A CYSTOCELE REPAIR PROCEDURE ON (B)(6), 2008. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT EXPERIENCED RECURRENT PELVIC PAIN, EROSION, RECURRENT INFECTION OF THE TISSUE AROUND THE MESH, AND A COLOVAGINAL FISTULA. THE DATE OF ONSET FOR EACH IS UNKNOWN. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other