BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFLUX

    MDR report key: 3708613 · Received March 19, 2014

    Report

    Report Number
    3009325614-2014-00010
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    January 1, 2005
    Report Date
    March 4, 2014
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED VIA A LITERATURE ARTICLE THAT A (B)(6) OLD FEMALE RECEIVED DEFLUX (DEXTRANOMER MICROSPHERES/HYALURONIC ACID) INJECTION INTO THE SUBMUCOSA OF THE URINARY BLADDER AS TREATMENT FOR LEFT-SIDED GRADE 3 VESICOURETERAL REFLUX (VUR). ADDITIONAL MEDICAL HISTORY INCLUDED RECURRENT URINARY TRACT INFECTIONS. CONCURRENT MEDICATIONS WERE NOT PROVIDED. IN 2005, THE PATIENT RECEIVED DEFLUX INTO THE VESICAL OSTIUM OF THE LEFT URETER. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT URINARY TRACT INFECTION. THREE YEARS AFTER DEFLUX IMPLANTATION, A MICTION CYSTOGRAPHY REVEALED THE PRESENCE OF LEFT-SIDED FIFTH-DEGREE VUR. ON UNKNOWN DATE, THE PATIENT UNDERWENT RE-IMPLANTATION OF THE URETER. AFTER OPENING THE BLADDER, A HARD INFLAMMATORY INFILTRATE IN THE AREA OF THE VESICAL OSTIUM WAS FOUND. HISTOPATHOLOGY OF THE 2 CENTIMETER URETERAL SEGMENT REVEALED A SIGNIFICANTLY EXFOLIATED TRANSITIONAL EPITHELIUM WITH A VISIBLE CHRONIC INFLAMMATORY INFILTRATE BENEATH. OUTSIDE THE MUSCULAR COAT, A FOCUS 2-MILLIMETERS IN DIAMETER WAS VISIBLE. IT WAS FORMED BY DROPLETS OF IATROGENIC ORIGIN AND SURROUNDED BY POLYNUCLEIC HISTIOCYTES. FOLLOWING SURGERY, THE URINARY TRACT INFECTIONS RESOLVED. SIX MONTHS LATER, A MICTION CYSTOGRAPHY WERE PERFORMED AND DID NOT SHOW ANY FEATURES OF REFLUX. THE AUTHORS FELT THAT THE EVENTS WERE RELATED TO DEFLUX. THE COMPANY FELT THE EVENTS WERE RELATED TO DEFLUX. SOURCE OF REPORT (LITERATURE): 1, MARCIN ZYCZKOWSKI, CENTRAL EUROPEAN JOURNAL OF UROLOGY, 2012, 65, FROM 230 TO 231, COMPLICATIONS FOLLOWING ENDOSCOPIC TREATMENT OF VESICOURETERIC REFLUX WITH DEFLUX-TWO CASE STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165102 DEFLUX AGENT, BULKING, INJECTABLE LNM Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention