BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER INTERMITTENT MAGIC3

    MDR report key: 4963061 · Received July 31, 2015

    Report

    Report Number
    1018233-2015-00264
    Event Type
    Injury
    Date Received
    July 31, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR EVALUATION. 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 IN (B)(6) 2015, ABDOMINAL PAIN AND CLOUDY, THICK 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
    498988 ROCHESTER INTERMITTENT MAGIC3 KOD ROCHESTER MEDICAL CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention