BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7889583 · Received September 19, 2018

    Report

    Report Number
    3000204189-2018-00010
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 19, 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

    CLINIC REPORTED THE PUMP WAS PROGRAMMED TO 30.0ML/HR WITH INTENDED RATE OF 3.0ML/HR. PATIENT WENT TO THE ER FOR THE ANTIDOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730310 WALKMED WALKMED 350VL FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R