BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGOLINE

    MDR report key: 2563085 · Received April 16, 2012

    Report

    Report Number
    2311923-2012-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    October 2, 2009
    Report Date
    April 16, 2012
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INJURY TO FINGER WHEN IT ENTERED THE FOOT FAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERGOLINE AMBITION 300 LEJ JK PRODUCTS & SERVICES, INC. AMBITION 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other