BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6039641 · Received October 19, 2016

    Report

    Report Number
    3006803715-2016-00158
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 20, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE PUMP POCKET. THE DEVICE WAS EXPLANTED AND DISPOSED OF BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691882 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other