BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT MAGIC3

    MDR report key: 5047598 · Received September 1, 2015

    Report

    Report Number
    1018233-2015-00329
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP 2130787
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "HOW TO PREPARE AND USE THE MAGIC 3 CATHETER. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE. MADE OF SILICONE ELASTOMER." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. SAMPLE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CYSTITIS FOLLOWING USE OF THE DEVICE. MEDICAL TREATMENT WAS REQUIRED. THE PATIENT EXPERIENCED PAINFUL URINATION, FEVER AND NOCTURIA. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RETURNED TO NORMAL. THE PATIENT'S MEDICAL HISTORY DID NOT INCLUDE URINARY TRACT INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577484 INTERMITTENT MAGIC3 MAGIC 3 KOD ROCHESTER MEDICAL CORP 2130787 NA 73600081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention