BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE SYSTEM

    MDR report key: 2801751 · Received October 11, 2012

    Report

    Report Number
    2183959-2012-02854
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 20, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO 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 APOGEE GRAFT WAS IMPLANTED GREATER THAN 12 MONTHS AGO. THE PT EXPERIENCED PAIN DURING VAGINAL EXAMINATION AND A MESH PROTRUSION WAS PALPABLE AT THE VAGINAL INCISION SITE, NO MESH EXTRUSION WAS FOUND. ON (B)(6) 2012, THE PT HAD A SURGICAL REVISION PROCEDURE TO RELEASE MESH "BAND CONSTRICTION FROM CONTRACTION." DETAILS OF THE ORIGINAL IMPLANT PROCEDURE ARE UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R