BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM CANISTER

    MDR report key: 1830719 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00171
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    THREE CANISTERS WERE CRACKED OUT OF THE BOX. THE CANISTERS WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM CANISTER PENUMBRA SYSTEM PUMP CANISTER BTA PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1