BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER INTERMITTENT MAGIC3

    MDR report key: 4963056 · Received July 31, 2015

    Report

    Report Number
    1018233-2015-00263
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 14, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A URINARY TRACT INFECTION, PAIN AT THE INSERTION SITE, BURNING WHILE URINATING AND ODOR IN HER URINE AS A RESULT OF USING THE DEVICE. THE PT WAS PRESCRIBED BACTRUM TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499260 ROCHESTER INTERMITTENT MAGIC3 KOD ROCHESTER MEDICAL CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention