BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032/041

    MDR report key: 1588997 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00082
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    February 12, 2009
    Report Date
    March 2, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO THAT WE HAVE WITH REGARD TO THIS INCIDENT WAS SUPPLIED BY OUR DISTRIBUTOR. WE HAVE NOT BEEN ABLE TO CONTACT THE PHYSICIAN OR HOSPITAL DIRECTLY. THE PRODUCTS WERE NOT RETURNED TO US AND WE ARE FILING THE MDR BASED ON THE INFO WE HAVE RECEIVED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN IN RESPONSE TO THE 483 ISSUED TO PENUMBRA ON AUGUST 28, 2009.

    Description of Event or Problem · 1

    THE PHYSICIAN STARTED WITH AN 041 SYSTEM BUT COULD NOT REACH THROMBUS SO HE CHANGED OUT FOR AN 032 SYSTEM AND HE COULD REACH. THE RESULT WAS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032/041 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1