BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFLUX

    MDR report key: 2191848 · Received January 12, 2007

    Report

    Report Number
    9710154-2007-00035
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    July 10, 2006
    Report Date
    January 11, 2007
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER NOTES THAT THE RELATIONSHIP OF THE ADVERSE EVENT TO THE INJECTION PROCEDURE IS PROBABLE AND THAT THE RELATIONSHIP OF THE ADVERSE EVENT TO THE DEVICE IS POSSIBLE. THE REPORTER ALSO NOTED THAT SCAR TISSUE FROM PREVIOUS PROCEDURES LIKELY CONTRIBUTED TO OBSTRUCTION.

    Description of Event or Problem · 1

    URETERAL OBSTRUCTION NOTED BY FLANK PAIN AND FEVER AND INCREASED SERUM CREATININE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFLUX INJECTABLE GEL FOR VUR LNM Q-MED AB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention OXYBUTYNIN| MITROFANOFF| NIFEDIPINE| CIPROFLOXACIN