BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIGEE SYSTEM

    MDR report key: 2921806 · Received January 15, 2013

    Report

    Report Number
    2183959-2013-00278
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    July 15, 2006
    Report Date
    December 20, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN PERIGEE SYSTEM WITH INTEPRO WAS IMPLANTED, THE DATE OF IMPLANT WAS NOT PROVIDED. INFORMATION RECEIVED INDICATES THAT ON (B)(6) 2006 VAGINAL DAMAGE/TEAR WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22232 PERIGEE SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention