BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DCS COIL

    MDR report key: 4100371 · Received September 18, 2014

    Report

    Report Number
    1226348-2014-00689
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K053160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CASHMERE COIL DETACHED PREMATURELY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS ¿ 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    CASHMERE COIL DETACHED PREMATURELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579850 UNKNOWN DCS COIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1