BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7883902 · Received September 17, 2018

    Report

    Report Number
    3000204189-2018-00009
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 17, 2018
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING END. THE PUMP INFUSED AT A PROGRAMMED RATE OF 4.75ML/HR. PATIENT WAS HOSPITALIZED AND RECEIVED AN ANTIDOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720974 WALKMED WALKMED 350VL FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization