BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE SYSTEM

    MDR report key: 3192558 · Received June 21, 2013

    Report

    Report Number
    2183959-2013-00839
    Event Type
    Injury
    Date Received
    June 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTP
    Report Source
    Manufacturer report

    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

    REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283638 APOGEE SYSTEM SURGICAL MESH, POLYMERIC OTP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1