BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT MAGIC3

    MDR report key: 4963028 · Received July 31, 2015

    Report

    Report Number
    1018233-2015-00256
    Event Type
    Injury
    Date Received
    July 31, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE. THE DEVICE HISTORY RECORD WAS REVIEWED & FOUND NOTHING THT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI, URGENCY, BURNING WHILE URINATING AS WELL AS ODOR WHEN URINATING AS A RESULT OF USING THE DEVICE. THE PATIENT WAS PRESCRIBED CIPRO TO TREAT THE INFECTION. THE PATIENT HAS A FOLLOW UP APPOINTMENT SCHEDULED W/HIS PHYSICIAN ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499002 INTERMITTENT MAGIC3 KOD ROCHESTER MEDICAL CORP. NA 73600125

    Patients

    Seq Age Sex Outcome Treatment
    1