BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFLUX

    MDR report key: 2823784 · Received August 6, 2008

    Report

    Report Number
    9710154-2008-00028
    Event Type
    Other
    Date Received
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT TREATED FOR GRADE II VUR ON (B)(6) 2008. PT WAS WITHOUT SYMPTOMS. ON (B)(6) 2008, A RENAL SONOGRAM WAS PERFORMED INDICATING LEFT HYDROURETERONEPHROSIS. ON (B)(6), LASIX WASHOUT RENAL SCAN INDICATED LEFT KIDNEY OBSTRUCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R MULTIVITAMINS| NITROFURANTOIN SUSP 3 ML, Q HS