BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 2060788 · Received March 11, 2011

    Report

    Report Number
    3005168196-2011-00107
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PENUMBRA SYSTEM SEPARATOR 041 PACKAGING WAS TAKEN OUT OF THE BOX. A HOLE WAS NOTED IN THE PACKAGING. THE PRODUCT WAS NOT USED IN THE PT. A NEW PENUMBRA SYSTEM SEPARATOR 041 WAS OPENED AND USED WITHOUT ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 NRY PENUMBRA, INC. F18562

    Patients

    Seq Age Sex Outcome Treatment
    1