BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7119422 · Received December 14, 2017

    Report

    Report Number
    3010079947-2017-00184
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 8, 2017
    Report Date
    November 13, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT LIKELY DEVELOPED AN INFECTION FROM OMMAYA EXPOSURE AND THE PUMP WAS SUBSEQUENTLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895374 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R