BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 3063692 · Received April 17, 2013

    Report

    Report Number
    3005099803-2013-02720
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS SEEN ON (B)(6) 2009 AND REPORTED THAT SHE WAS DOING WELL; HOWEVER, SHE WAS TREATED FOR A VAGINAL INFECTION WITH FLAGYL. THE PATIENT PRESENTED NO COMPLICATIONS IN ANOTHER, UNRELATED VISIT ON (B)(6) 2009. 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
    166269 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502111 0ML9061105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention