BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 11549586 · Received March 23, 2021

    Report

    Report Number
    9611812-2021-00011
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    March 23, 2021
    Manufacturer
    DORNIER MEDTECH AMERICA
    Product Code
    GEX
    UDI-DI
    04049958003158
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    COMPLAINT INFORMATION WAS RECEIVED FOR A HOLIUM FIBER WHICH WAS IDENTIFIED TO HAVE BROKE. NO REPORTS OF INJURY OR PATIENT COMPLICATION WERE REPORTED TO DORNIER MEDTECH AMERICA DUE TO PRODUCT COMPLAINT. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00040 ON 09/14/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449727 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA K2013151 F2219R 04049958003158

    Patients

    Seq Age Sex Outcome Treatment
    1