BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT MAGIC3

    MDR report key: 5010202 · Received August 14, 2015

    Report

    Report Number
    1018233-2015-00294
    Event Type
    Injury
    Date Received
    August 14, 2015
    Report Date
    July 23, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER IS UNK THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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 PTS 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 (B)(6). URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE, DO NOT RESTERILIZE. MADE OF SILICONE ELASTOMER". (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A (B)(6) AS A RESULT OF USING THE DEVICE. THE PT WAS TREATED WITH CIPRO TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537976 INTERMITTENT MAGIC3 KOD ROCHESTER MEDICAL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention