BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEPRO MESH GRAFT

    MDR report key: 2101537 · Received May 20, 2011

    Report

    Report Number
    2183959-2011-00168
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL 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

    INFO RECEIVED INDICATES AN INTEPRO MESH GRAFT WAS IMPLANTED ON (B)(6) 2007. REPORTEDLY AFTER THE IMPLANT PT HAS EXPERIENCED PAIN, EROSION OF INTERNAL TISSUE AND DYSPAREUNIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S