BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3953848 · Received July 23, 2014

    Report

    Report Number
    3005168196-2014-00483
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE STAFF TOUCHED THE NON-STERILE FIELD WHILE TAKING THE COIL OUT OF THE LOOP. A NEW COIL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431471 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F40273

    Patients

    Seq Age Sex Outcome Treatment
    1