BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM CANISTER

    MDR report key: 1830638 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00197
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    August 13, 2008
    Report Date
    August 19, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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

    UPON INITIAL PUMP SET-UP BEFORE THE CASE, TWO CRACKED CANISTERS WERE FOUND. A THIRD UNIT WAS OPENED AND SET-UP CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO PT OR DOCTOR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM CANISTER POWER SUCTION PUMP CANISTER BTA PENUMBRA, INC. B000006

    Patients

    Seq Age Sex Outcome Treatment
    1