BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGOLINE

    MDR report key: 2546872 · Received April 16, 2012

    Report

    Report Number
    9615023-2012-00008
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    May 22, 2009
    Report Date
    April 16, 2012
    Manufacturer
    JK PRODUCTS GMBH
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTICE OF LOSS FROM INSURED ADVISING A FIRE IN A TANNING SALON ALLEGEDLY CAUSE BY IMPROPER BULB INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERGOLINE CLASSIC 450 LEJ JK PRODUCTS GMBH CLASSIC 450 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other