BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 7310369 · Received March 2, 2018

    Report

    Report Number
    3002647932-2018-00004
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    October 20, 2017
    Report Date
    March 2, 2018
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    UDI-DI
    08717591240266
    PMA / PMN Number
    P040050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO GET MORE INFORMATION REGARDING THE INCIDENT. THE INCIDENT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE MUCOSA WAS PERFORATED, EXPOSING THE MPQ, WHICH MAY HAVE LET TO THE STONE FORMATION. AT THIS POINT, WE ARE CONSIDERING THE REMOVAL OF THE STONE TO BE MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR REFORMING BLADDER STONES.

    Description of Event or Problem · 1

    FEMALE PATIENT WHO PRESENTED WITH URINARY INCONTINENCE WAS INITIALLY TREATED VIA PUBOVAGINAL SLING IN 2005. IN (B)(6) 2013, PATIENT WAS GIVEN A SUBURETHRAL INJECTION OF MACROPLASTIQUE (MPQ) WITH GOOD RESULTS AND FOLLOW UP THROUGH 2014. IN (B)(6) 2017, THE PATIENT WAS REFERRED BACK TO HER DOCTOR FOR POSSIBLE BLADDER STONES - THE PATIENT REPORTED MILD BLADDER IRRITABILITY AND MINOR RECURRENT STRESS URINARY INCONTINENCE (SUI). THE PATIENT WAS FOUND TO HAVE MUCOSA WHICH HAD PERFORATED EXPOSING THE MPQ IMPLANT, AND ALSO HAD A BLADDER STONE WHICH DEVELOPED ON TOP OF THE EXPOSED MPQ IMPLANT. THE PATIENT UNDERWENT A CYSTOLITHOLAPAXY IN (B)(6) 2017 TO REMOVE THE BLADDER STONES. IT IS UNCLEAR IF THE MPQ IMPLANT WAS REMOVED, OR IF OTHER TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154534 MACROPLASTIQUE IMPLANTS URETHRAL BULKING AGENT LNM UROPLASTY, LLC MPQ-2.5 08717591240266

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention