BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER INTERMITTENT MAGIC3

    MDR report key: 4963055 · Received July 31, 2015

    Report

    Report Number
    1018233-2015-00257
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    February 17, 2016
    Manufacturer
    ROCHESTER MEDICAL CORP
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Additional Manufacturer Narrative · 1

    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.

    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 TO 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. DEVICE DISCARDED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED THE PATIENT ALLEGEDLY DEVELOPED THE URINARY TRACT INFECTION DUE TO E COLI. WHILE TAKING THE FOLLOWING MEDICATIONS: BACTRIM, DITROPAN, MACROBID, PHENAZOPYRIDINE, PAIN MEDICATION, IBUPROFEN, POLYETHYLENE GLYCOL POWDER, VITAMIN D2, DRISDOL, PROZAC, LYRICA, VALTREX, RESPIRATORY INHALOR SPRAY, ASPIRIN AND OTC MEDICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A URINARY TRACT INFECTION AS A RESULT OF USING THE DEVICE. THE PT WAS PRESCRIBED CEPTRA TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498875 ROCHESTER INTERMITTENT MAGIC3 KOD ROCHESTER MEDICAL CORP NA 73600219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention