BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMUM BLADE AND KNIFE 15 DEGREES

    MDR report key: 12148009 · Received July 9, 2021

    Report

    Report Number
    1211998-2021-00044
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    Removal / Correction Number
    Z-0504-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THEY RECEIVED MULTIPLE PACKAGES OF PART 378235 WITH SAFETY SHIELDS RETRACTED: THE BLADE IS EXPOSED WHILE IN PACKAGE. SENIOR SALES REPRESENTATIVE MET WITH CUSTOMER AND DISCOVERED SURGEON RECEIVED A SMALL PUNCTURE TO THE MIDDLE OF HIS RIGHT HAND DUE TO KNIFE BEING EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041107 OPTIMUM BLADE AND KNIFE 15 DEGREES OPHTHALMIC KNIVE HNN BEAVER-VISITEC INTERNATIONAL, INC. 873235 6017566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other