BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROPLASTIQUE IMPLANTS

    MDR report key: 8595744 · Received May 9, 2019

    Report

    Report Number
    3002647932-2019-00003
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    UROPLASTY, LLC
    Product Code
    LNM
    PMA / PMN Number
    P040050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MACROPLASTIQUE IMPLANTS ARE NOT INDICATED FOR TREATMENT OF VUR WITHIN THE UNITED STATES (ONLY FEMALE SUI), HOWEVER THE VUR INIDICATION EXISTS FOR ALL GEOGRAPHIES OUTSIDE THE US. THIS EVENT IS BEING CONSERVATIVELY REPORTED TO FDA AS A) IT WAS UNCLEAR BASED ON THE CONTENT OF THE PUBLISHED CASE STUDY WHETHER OR NOT THE MPQ WAS REQMOVED AT THE TIME OF BLADDER STONE REMOVAL AND B) DUE TO THE FACT THAT TREATMENT WITH MPQ FOR VUR IS SIMILAR TO THAT FOR SUI AND THEREFORE THIS TYPE OF EVENT HAS THE POTENTIAL TO OCCUR WITHIN THE US. ADDITIONALLY, THIS REPORT IS BEING SUBMITTED TO FDA MORE THAN 30 DAYS AFTER THE INITIAL AWARENESS DATE AS THE LITERATURE WAS PUBLISHED IN (B)(4) AND TRANSLATIONS OF THE ARTICLE WERE NECESSARY IN ORDER TO EVALUTE WHETHER OR NOT THE EVENT DESCRIBED WAS REPORTABLE.

    Description of Event or Problem · 1

    THIS EVENT WAS DISCOVERED DURING A LITERATURE SEARCH RELATED TO MACROPLASTIQUE (MPQ) FOR TREATMENT OF VESICOURETERAL REFLUX (VUR) AND WAS FOUND IN THE FORM OF A CASE STUDY. A (B)(6) YEAR OLD MAN RECEIVED MPQ TREATMENT FOR VUR 7 YEARS PREVIOUS. MICTURATING CYSTOURETHROGRAPHY HAD SHOWN THAT THE VUR HAD DISAPPEARED. THE PATIENT PRESENTED WITH LEFT ABDOMINAL PAIN AS A MAIN COMPLAINT. NO HYDRONEPHROSIS WAS SHOWN IN COMPUTER TOMOGRAPHY HOWEVER AN APPROXIMATELY 8.3 MM SIZED STONE WAS SHOWN IN THE LEFT VESICOURETERAL JUNCTION NEAR WHERE THE MPQ HAD BEEN PREVIOUSLY INJECTED. URETERAL ENDOSCOPY SHOWED A PROTUBERANT GRANULATION TISSUE INSIDE THE BLADDER DIRECTLY BELOW THE LEFT URETERAL ORIFICE WHICH WAS FIRMLY ATTACHED TO THE STONE. THE STONES WERE REMOVED VIA HOLMIUM: YAG LASER, CRUSHED AND THEN REMOVED FROM THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387094 MACROPLASTIQUE IMPLANTS AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM UROPLASTY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention