BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 8422708 · Received March 14, 2019

    Report

    Report Number
    3000204189-2019-00001
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 5, 2019
    Report Date
    March 14, 2019
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTED THE PUMP MALFUNCTIONED OVER THE WEEKEND. PATIENT RETURNED TO THE CLINIC AND THE NURSE RESTARTED THE PUMP. THE NEXT DAY THE PATIENT RETURNED AFTER THE FULL DOSE WAS GIVEN. NO ADVERSE EVENT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216021 WALKMED WALKMED 350VL FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other