BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 3881630 · Received April 8, 2014

    Report

    Report Number
    9615741-2014-00011
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    March 20, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS "BREAKAGE OF THE PLASTIC HANDLE PART." THE DEVICE WAS NOT IN CONTACT WITH A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212045 QUICK-COUPLING GAUTHIER 103800 NA LXH NEWDEAL SAS EAFF

    Patients

    Seq Age Sex Outcome Treatment
    1