BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 8674294 · Received June 6, 2019

    Report

    Report Number
    3010079947-2019-00079
    Event Type
    Death
    Date Received
    June 6, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 10, 2019
    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 PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469767 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death