BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP CANISTER

    MDR report key: 1830793 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00244
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    PENUMBRA INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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

    AS A PENUMBRA SALES REPRESENTATIVE WAS PREPARING FOR AN IN-SERVICE, THEY NOTICED THAT A CANISTER WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA ASPIRATION PUMP CANISTER POWERED SUCTION PUMP CANISTER BTA PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1