BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 7726871 · Received July 27, 2018

    Report

    Report Number
    3010079947-2018-00156
    Event Type
    Death
    Date Received
    July 27, 2018
    Report Date
    June 28, 2018
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. THE DATE AND CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568713 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death