BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 6096836 · Received November 11, 2016

    Report

    Report Number
    3002647932-2016-00008
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 11, 2016
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BASED ON THE REPORTED MIGRATION OF THE MACROPLASTIQUE. WHILE THERE WAS NO INJURY REPORTED AS A RESULT OF THIS MIGRATION, THERE IS A POTENTIAL FOR INJURY OR SURGICAL INTERVENTION IN CASES WHERE MIGRATION OCCURS. IN FOLLOW-UP COMMUNICATIONS WITH THE PHYSICIAN, HE REPORTED THAT HE BELIEVED THE BOLUS TO STILL BE ENCAPSULATED AND THE PATIENT IS REPORTING THAT SHE CONTINUES TO BE DRY WITH NO COMPLAINTS OF INCONTINENCE. THE PHYSICIAN BELIEVES THAT THE IMPLANT IS CONTINUING TO WORK AND PROVIDE BULKING. THE PATIENT HAS RECEIVED TWO IMPLANTATIONS. THE FIRST ON (B)(6) 2015 ((B)(4)) AND THE SECOND ON (B)(6) 2016 ((B)(4)). DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT WAS IN THE OFFICE FOR AN ESTABLISHED VISIT. SHE NOTICED A PROTRUSION INTO HER VAGINAL CANAL DURING INTERCOURSE. THE DR. ORDERED AN MRI AND IT SHOWS A MIGRATION OF THE MACROPLASTIQUE. AS THIS IS NOT BOTHERSOME TO THE PATIENT, THE DR HAS ELECTED TO OBSERVE THIS. THE PATIENT WILL RETURN IN (B)(6) OR WILL CALL IF THE ISSUE BECOMES BOTHERSOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746736 MACROPLASTIQUE IMPLANTS URETHRAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5 B15G1302

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR