BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE

    MDR report key: 2071790 · Received April 20, 2011

    Report

    Report Number
    2183959-2011-00142
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    September 14, 2010
    Report Date
    March 22, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    CLINICAL STUDY, (B)(4). A PERIGEE GRAFT WAS IMPLANTED ON (B)(6) 2010, DUE TO RECURRING CYSTOCELE. ON (B)(6) 2010, THIS PT HAD A F/U VISIT. DURING EXAMINATION, GRANULATED TISSUE WAS FOUND IN THE AREA AROUND THE CENTER OF THE PERIGEE INCISION. THE AFFECTED TISSUE WAS CAUTERIZED WITH SILVER NITRATE. THIS EVENT IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIGEE SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other