BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1913113 · Received November 8, 2010

    Report

    Report Number
    1913113
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ALCON
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING SURGERY ON HIS RIGHT EYE WHEN IT WAS NOTICED THAT THE MEMBRANE PEELER CUTTER BLADE HAD A CHIP IN IT. THE SURGEON REMOVED FROM THE PATIENT'S EYE WHAT APPEARED TO BE A CHIP FROM THE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MEMBRANE PEELER CUTTER HQE ALCON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR