BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 3810693 · Received March 21, 2014

    Report

    Report Number
    9615741-2014-00009
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    March 4, 2014
    Manufacturer
    NEWDEAL S.A.S.
    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: "CUSTOMER WANTS TO RETURN THE DEVICE FOLLOWING A MANUFACTURING ISSUE." ON (B)(6) 2014, ADDITIONAL INFORMATION WAS PROVIDED. THE REPORTED ISSUE 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
    169203 QUICK-COUPLING GAUTHIER 103800 NA LXH NEWDEAL S.A.S. EPNZ

    Patients

    Seq Age Sex Outcome Treatment
    1