BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7109632 · Received December 12, 2017

    Report

    Report Number
    3000204189-2017-00017
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE FROM CLINIC NOTIFIED WALKMED, A PATIENT RETURNED EARLY FOR A COMPLETED TREATMENT. NURSES CONFIRM PUMPS SETTINGS AND LOCKED SETTING PRIOR TO RELEASE. PUMP WAS RETURNED WITH AN INCREASED DELIVERY RATE AND THE PUMP WAS UNLOCKED. NO PATIENT ADVERSE EFFECTS OR INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888804 WALKMED WALKMED 350 VL FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1