BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFLUX

    MDR report key: 2823779 · Received July 11, 2008

    Report

    Report Number
    9710154-2008-00027
    Event Type
    Other
    Date Received
    July 11, 2008
    Report Date
    July 10, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    PMA / PMN Number
    P000029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OF NUMBNESS AND TINGLING IN THE LOWER EXTREMITIES WAS REPORTED TO A SALES REP. THE PHYSICIAN HAS RECEIVED AN ADVERSE EVENT FORM AND PROMISED TO GET FURTHER DETAILS FROM THE PT'S FILE, BUT NO FORM HAS BEEN RECEIVED SO FAR. F/U FOR ADDITIONAL INFO CONTINUES. THE SALES REP WAS INFORMED THAT THE PT WAS AN ADULT AND TREATED FOR VESICOURETERAL REFLUX ABOUT 10 MONTHS AGO. AT AN UNK TIME AFTER TREATMENT, THE PT COMPLAINED ABOUT NUMBNESS AND TINGLING IN HER FEET AND LOWER LEGS. AT THIS TIME, WE DO NOT BELIEVE THE ADVERSE EVENT IS ATTRIBUTABLE TO DEFLUX TREATMENT OR TO THE TREATMENT PROCEDURE. AGAIN, F/U WITH THE PHYSICIAN WILL CONTINUE.

    Description of Event or Problem · 1

    PT COMPLAINED OF NUMBNESS AND TINGLING IN THE FEET AND LOWER LEGS.

    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