BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEOVERY FILTER SYSTEM

    MDR report key: 2841356 · Received October 23, 2012

    Report

    Report Number
    2020394-2012-00235
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD "SEVERAL PIECES OF THE FILTER SYSTEM FRACTURE, AND MIGRATED TO THE PATIENT'S LUNGS." NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEOVERY FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1