BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPHTHO-BURR 1.0MM

    MDR report key: 1971992 · Received January 12, 2011

    Report

    Report Number
    1971992
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 12, 2011
    Manufacturer
    BEAVER VISITEC, INTERNATIONAL
    Product Code
    HQS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN IN URGENT CARE. MD WAS ATTEMPTING TO REMOVE A RUST RING WITH AN OPHTHALMIC BURR DEVICE. THE BURR DEVICE THAT WAS USED CREATED METAL SHARDS THAT WENT INTO THE PATIENT'S EYE, LEAVING A METALLIC FOREIGN BODY AFTER USE. THE PATIENT WAS REFERRED TO OPHTHALMOLOGY FOR FOLLOW UP. PATIENT WAS INFORMED REGARDING THE BURR ISSUE. PATIENT DID NOT COMPLAIN OF VISION DISTURBANCE FOLLWOING PROCEDURE. ALCAINE DROPS WERE USED PREVIOUS TO PROCEDURE SO PATIENT REMAINED TOPICALLY ANESTHETIZED UPON DISCHARGE TO THE OPHTHALMOLOGY OFFICE FOLLOWING THE DEVICE MALFUNCTION. IT APPEARS THAT THE PLASTIC SHEATHS INSIDE THE SEALED PACKAGES ARE NOT INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHO-BURR 1.0MM OPHTHALMIC BURR HQS BEAVER VISITEC, INTERNATIONAL * 68379800

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R