BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2935931 · Received January 30, 2013

    Report

    Report Number
    3005099803-2013-00436
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6), 2007. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN, THE PATIENT HAD CONTINUED SUI FOLLOWING THE PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT IS "SEMI OVER WEIGHT AND A HEAVY SMOKER WITH A CHRONIC COUGH" AND THIS MAY HAVE CONTRIBUTED TO HER SUI SENSATION. IN 2008, THE PATIENT UNDERWENT A SECOND PROCEDURE. SHE HAD NO COMPLICATIONS FOLLOWING THIS PROCEDURE BUT STILL FELT SUI-LIKE SYMPTOMS. THE PHYSICIAN AGAIN PROPOSED THAT THE SYMPTOMS MAY BE DUE TO THE PATIENT'S SMOKING HABITS. 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
    41228 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention