BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3871962 · Received June 13, 2014

    Report

    Report Number
    2183959-2014-00218
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR, THE PATIENT WAS "TRANSFUSED 2 DAYS POST-OP." THE PATIENT WAS "OK" AFTER THE TRANSFUSION, NO ADDITIONAL TREATMENT OR REVISION IS PLANNED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351114 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention