BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER FLEXIPULSE

    MDR report key: 7720203 · Received July 25, 2018

    Report

    Report Number
    1037955-2018-00046
    Event Type
    Injury
    Date Received
    July 25, 2018
    Report Date
    July 20, 2018
    Manufacturer
    DORNIER MEDTECH LASER GMBH
    Product Code
    GEX
    PMA / PMN Number
    K083500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER ACTION WAS TAKEN DUE TO THE FACT THE CUSTOMER INFORMED DORNIER MEDTECH AMERICA, INC. THAT IT WAS AN OPERATOR ERROR AND NOT THE FAULT OF THE DEVICE. DORNIER MEDTECH AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012002.

    Description of Event or Problem · 0

    PATIENT BURN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559408 DORNIER FLEXIPULSE DIODE LASER GEX DORNIER MEDTECH LASER GMBH FLEXIPULSE DFP0314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other