BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMEYES

    MDR report key: 12974000 · Received December 10, 2021

    Report

    Report Number
    1211998-2021-00066
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS APPLICABLE TO THE DEVICE THAT IS INDICATED AS STABBING THE TECHNICIAN. A ECOND SAFETY KNIFE THAT WAS REPORTED RETRACTED WAS FILED UNDER MDR 1211998-2021-00067.

    Description of Event or Problem · 0

    "CUSTOMER STATED 2 SAFETY KNIVES, SUB-PART 378210, IN THEIR CUSTOM EYES KIT, PART 58000516, HAD RETRACTED PROTECTION SHIELDS: 1 WAS RETRACTED AND 1 WAS ALSO RETRACTED AND THE TECH WAS STABBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876621 CUSTOMEYES CUSTOMEYES KIT, OPTHALMIC KNIFE HNN BEAVER-VISITEC INTERNATIONAL, INC. 6045913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown