BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3260321 · Received August 1, 2013

    Report

    Report Number
    3005168196-2013-00302
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. HOSPITAL DISCARDED DEVICE.

    Description of Event or Problem · 1

    WHEN PUSHER/COIL ASSEMBLY WAS REMOVED FORM PACKAGE THE HYPOTUBE WAS KINKED. THE PRODUCT WAS NEVER USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360938 PENUMBRA COIL 400 HCR, KRD HCG PENUMBRA, INC. F29856

    Patients

    Seq Age Sex Outcome Treatment
    1