BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-BODY INJECTOR

    MDR report key: 6839086 · Received September 1, 2017

    Report

    Report Number
    MW5071911
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 30, 2017
    Manufacturer
    AMGEN INC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEULASTA ON BODY INJECTOR FELL OFF OF PATIENT AT HOME. DATES OF USE: (B)(6)2017. DIAGNOSIS OR REASON FOR USE: DRUG INDUCED NEUTROPENIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618414 ON-BODY INJECTOR NEULASTA NSC AMGEN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention