BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6028356 · Received October 13, 2016

    Report

    Report Number
    3006803715-2016-00165
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    August 15, 2016
    Report Date
    September 14, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CURRENTLY DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE PUMP POCKET SITE, AND THE PUMP WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679728 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other