BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3902517 · Received June 30, 2014

    Report

    Report Number
    2183959-2014-00254
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN ELEVATE POSTERIOR GRAFT IN (B)(6) 2011. THE PATIENT HAD A 5MM EXTRUSION REMOVED ON (B)(6), 2014. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380433 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R