BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 5966691 · Received September 21, 2016

    Report

    Report Number
    3002647932-2016-00002
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT BASED UPON A LITERATURE REVIEW OF IMAGES IN UROGYNECOLOGY, DOI 10.1007/S00192-016-3120-7. UROPLASTY HAS REACHED OUT TO THE DOCTOR FOR MORE INFORMATION AND WILL SUBMIT A FOLLOW-UP SHOULD MORE INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A FEMALE PATIENT RECEIVED MACROPLASTIQUE FOR STRESS URINARY INCONTINENCE. AFTER 6 MONTHS, THE PATIENT NOTED A SUBURETHRAL MASS. THE MASS WAS ASYMPTOMATIC, EXCEPT THE PATIENT NOTED BODY IMAGE CONCERNS RELATED TO THE MASS PREVENTING INITIATION OF A SEXUAL RELATIONSHIP. THE PATIENT REQUESTED REMOVAL 18 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617492 MACROPLASTIQUE IMPLANTS URETHRAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR