BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 6031298 · Received October 14, 2016

    Report

    Report Number
    3002647932-2016-00004
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    April 12, 2015
    Report Date
    October 14, 2016
    Manufacturer
    UROPLASTY LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED BASED UPON FDA FEEDBACK.

    Description of Event or Problem · 1

    A PATIENT PRESENTED TO HER PHYSICIAN WHAT WAS DESCRIBED AS A MIGRATION OF THE MACROPLASTIQUE (MPQ) IMPLANT. UPON INSPECTION THE MPQ HAD MIGRATED NEAR HER VULVA AND WAS SURGICALLY REMOVED. TWO MASSES ROUGHLY THE SIZE OF QUAIL EGGS WERE REMOVED. THE PATIENT HAD RECEIVED THE MPQ IMPLANT APPROXIMATELY 3 YEARS PREVIOUSLY DURING A ROUTINE PROCEDURE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681630 MACROPLASTIQUE IMPLANTS URETHRAL BULKING AGENT LNM UROPLASTY LLC MPQ-2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention