BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCILOG METHADONE DISPENSER

    MDR report key: 6112968 · Received November 16, 2016

    Report

    Report Number
    MW5066109
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SCILOG
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDICATION PUMP DISPENSED OVERAGE OF MEDICATION DOSES. THERE WAS NO HARM TO PATIENTS. THIS PUMP WORKS WITH THE (B)(4) AVATAR DISPENSING SYSTEM. VENDOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759178 SCILOG METHADONE DISPENSER LIQUID DISPENSING SYSTEMS, PUMP KYX SCILOG LABTEC METH STOCK 6515-438804

    Patients

    Seq Age Sex Outcome Treatment
    1