BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASERPEEL SOFTMET 5G

    MDR report key: 1301963 · Received January 29, 2009

    Report

    Report Number
    MW5009798
    Event Type
    Injury
    Date Received
    January 29, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 29, 2009
    Manufacturer
    BEIJING TOPLASER TECHNOLOGY CO. LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN CONDUCTING THE TREATMENT SERVICE USED IMPROPER PROTOCOL SETTING ON THE DEVICE RESULTING IN THE "USE ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERPEEL SOFTMET 5G ERBIUM LASER UNIT GEX BEIJING TOPLASER TECHNOLOGY CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN