BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 7277998 · Received February 16, 2018

    Report

    Report Number
    3002647932-2018-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    UDI-DI
    08717591240266
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN A RECENT PUBLICATION IN THE INTERNATIONAL UROGYNECOLOGY JOURNAL IT WAS NOTED THAT A PATIENT EXPERIENCED MIGRATION OF THE MPQ IMPLANT INTO HER VAGINA. A POSTMENOPOSAL WOMAN UNDERWNT PERIURETHRAL BULING WITH MPQ IN 2014 AND PRESENTED IN 2015 COMPLAINING OF A VAGINAL MASS. UPON EXAMINATION A FIRM 2-CM LATERAL PERIURETRAL MASS WAS OBSERVED. THE MASS WAS EXCISED AND THE PATIENT REPORTEDLY HEALED WELL. PATHOLOGY OF THE MASS RETURNED AS A FOREIGN BODY GIANT CELL REACTION WITH REFRACTILE GEL-LIKE MATERIAL CONSISTENT WITH MPQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119976 MACROPLASTIQUE IMPLANTS URETHRAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5 08717591240266

    Patients

    Seq Age Sex Outcome Treatment
    1