BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE

    MDR report key: 4853716 · Received June 18, 2015

    Report

    Report Number
    2183959-2015-14552
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    April 9, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED - (B)(4): AMS APOGEE PC WITH INTEXEN LP - (B)(4), AMS APOGEE SYSTEM - (B)(4), AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4), AMS ELEVATE (NOT SPECIFIED) - (B)(4), AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4), AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4), AMS ELEVATE PC POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4), AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE - (B)(4), AMS PERIGEE SYSTEM - (B)(4), AMS PERIGEE SYSTEM WITH INTEPRO - (B)(4), AMS PERIGEE SYSTEM WITH PC COATED INTEPRO LITE - (B)(4), UNKNOWN GRAFT MESH - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED AN UNSPECIFIED INJURY. THE MESH REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396117 AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE MESH, SURGICAL, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GYNECARE| PERIGEE| GYNECARE| PERIGEE