BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC 2FR MST KIT

    MDR report key: 2602922 · Received May 24, 2012

    Report

    Report Number
    2925153-2012-00002
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 22, 2012
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    LJS
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. FOLLOW UP WILL BE PROVIDED AS ADDITIONAL INFORMATION IS RECEIVED AND COMPLAINT INVESTIGATION ANALYSIS ((B)(4)) IS COMPLETED. THE DEVICE HAS NOT BEEN RETURNED TO MANUFACTURING TO DATE. THE COMPLAINANT NOTIFIED NEO MEDICAL STATING THE DEVICE FOR EVALUATION WILL BE RETURNED BY (B)(6) 2012. CAR ((B)(4)).

    Description of Event or Problem · 1

    BREAK-AWAY INTRODUCER WOULD NOT BREAKAWAY, THERE DID NOT APPEAR TO BE A SEAM TO PEEL THE INTRODUCER APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMAGIC 2FR MST KIT 2FR MST KIT LJS NEO MEDICAL, INC. 1958-004 1006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention