BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 3120008 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03648
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THERE WERE NO PATIENT COMPLICATION OR COMPLAINTS PRESENTED UNTIL A VISIT IN LATE 2008. THE PATIENT WAS EXPERIENCING LEAKAGE, AND THE PHYSICIAN PERFORMED A PROCEDURE TO HELP. DURING ANOTHER VISIT IN 2009, THE PATIENT PRESENTED WITH COMPLAINTS OF URINARY RETENTION FOR WHICH THE PHYSICIAN HAD A FOLEY CATHETER INSERTED IN ORDER TO RELIEVE SYMPTOMS, AND IT RESOLVED THE ISSUE. IN (B)(6) 2009, THE PATIENT HAD COMPLAINTS OF LEFT-SIDED GROIN PAIN, PUBIC TENDERNESS, AND DYSPAREUNIA. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221953 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention