BEUDAMED
    FDA Adverse Event Other Summary report: N

    FULL SET OF INSTRUMENTS(CONTAINER AND ANCILLARY)

    MDR report key: 601264 · Received May 4, 2005

    Report

    Report Number
    9615741-2005-00010
    Event Type
    Other
    Date Received
    May 4, 2005
    Report Date
    May 4, 2005
    Manufacturer
    NEWDEAL S.A.
    Product Code
    LRP
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER FACILITY ORDERED A DEVICE FOR 1ST MTP ARTHRODESIS VIA TELEPHONE. HOWEVER, THE ORDER WAS INTERPRETATED AS AN ORDER 1ST MTP PROSTHESIS. THE ERROR WAS NOT DISCOVERED UNTIL THE SURGERY STARTED. PT WAS UNDER LOCAL ANESTHESIA. ANOTHER DIFFERENT DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT DELAYED BUT SURGEON APPLIED ANOTHER METHOD OF SURGERY DUE TO USING DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL SET OF INSTRUMENTS(CONTAINER AND ANCILLARY) HALLU ASSOCIATED INSTRUMENTS LRP NEWDEAL S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *