BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7770717 · Received August 9, 2018

    Report

    Report Number
    3000204189-2018-00007
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 21, 2018
    Report Date
    August 7, 2018
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT INITIALLY CALLED THE MANUFACTURER'S HOTLINE TO SAY HIS PUMP WAS BEEPING AND READING "END". INFUSION SCHEDULED TO END THE NEXT DAY. CLINIC NOTIFIED WALKMED THE PUMP WAS PROGRAMMED INCORRECTLY. NO ADVERSE EVENT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610062 WALKMED WALKMED 350VL FRN WALKMED, LLC 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other