BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2013660 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00055
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: BOTH BOXES SHOW EVIDENCE OF ROUGH HANDLING, BUT THE INNER ENVELOPES APPEAR UNAFFECTED. THE INCIDENT IS CONFIRMED AS REPORTED. 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 PRODUCTS WERE DAMAGED IN TRANSIT. THE HOSPITAL DID NOT FEEL COMFORTABLE PUTTING THEM INTO CLINICAL USE. THIS MDR IS ASSOCIATED WITH 2005168196-2010-00125 WHICH PERTAINS TO PENUMBRA SYSTEM REPERFUSION CATHETER 026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F16273

    Patients

    Seq Age Sex Outcome Treatment
    1