BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFLUX INJECTABLE GEL

    MDR report key: 7346980 · Received March 16, 2018

    Report

    Report Number
    3009443653-2018-00009
    Event Type
    Death
    Date Received
    March 16, 2018
    Report Date
    February 22, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. A DEVICE LOT NUMBER WAS NOT REPORTED, SO A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PUBLISHED ARTICLE TITLED "DETERIORATION OF AUTOIMMUNE CONDITION ASSOCIATED WITH REPEATED INJECTION OF DEXTRANOMER/HYALURONIC ACID COPOLYMER: A CASE REPORT" REPORTS A DIAGNOSED CASE OF URETERAL STENOSIS APPROXIMATELY 2 YEARS AFTER INJECTION. A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT ENDOSCOPIC DEFLUX INJECTION (EDI) FOR THE TREATMENT OF BILATERAL VUR OF GRADE 2. ANOTHER EDI WAS PERFORMED BECAUSE CYSTOURETHROGRAM AT 3 MONTHS POST-OPERATIVE SHOWED A PERSISTENT LEFT VUR OF GRADE 2. ONE AND A HALF YEARS AFTER, SHE CLAIMED LEFT FLANK PAIN. ULTRASOUND EXAMINATION SHOWED LEFT HYDRONEPHROSIS HYDROURETER, AND DELAYED EXCRETION FROM THE LEFT KIDNEY WAS OBSERVED BY MAG3. DELAYED ONSET OF URETERAL STENOSIS WAS DIAGNOSED, AND A URETERAL STENT WAS PLACED. SHE ALSO PRESENTED WITH ERYTHEMA ON BOTH CHEEKS AND RAYNAUD¿S PHENOMENON; AUTOIMMUNE DISEASE WAS SUSPECTED. SINCE A RELATIONSHIP WITH THE AUTOIMMUNE DISEASE WAS ALSO SUSPECTED, A RISK OF DEVELOPING A HETEROCHRONIC RIGHT URETERAL STENOSIS WAS CONCERNED, AND URETEROCYSTONEOSTOMY (UCN) ON BOTH SIDES WAS PERFORMED, WITH SATISFACTORY POSTOPERATIVE COURSE. SIGNIFICANT INFILTRATION OF EOSINOPHIL TO THE AREA OF URETERAL STENOSIS WAS OBSERVED HISTOPATHOLOGICALLY, AND THE PATIENT DIED OF PULMONARY HEMORRHAGE DUE TO THROMBOTIC THROMBOCYTOPENIC PURPURA 4 MONTHS AFTER UCN. REACTIVE STENOSIS ACCOMPANIED BY ALLERGY WAS SUGGESTED IN THIS CASE. IT WAS CONSIDERED THAT THE TREATMENT OF EDI SHOULD BE DISCUSSED MORE CAREFULLY TO A PATIENT WHO PREDISPOSES TO ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188735 DEFLUX INJECTABLE GEL AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE LNM BAUSCH + LOMB DEFLUX INJECTABLE GEL

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death| R