BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND BLADE

    MDR report key: 1612102 · Received February 22, 2010

    Report

    Report Number
    MW5014816
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    May 1, 2007
    Report Date
    February 22, 2010
    Manufacturer
    UNK
    Product Code
    HNN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RADIAL KERATOMY PERFORMED (B) (6). IN THE LAST 2-3 YEARS, PATIENT HAS BEEN EXPERIENCING HIS CORNEAS GOING FLAT (ESPECIALLY DISTANCE). THIS CONDITION CANNOT BE CORRECTED WITH LENSES OR PROCEDURES. PATIENT IS LOSING DRIVERS LICENSE DUE TO POOR VISION. PHYSICIAN STATED THAT IF HE DIDN'T HAVE THIS PROCEDURE DONE THIS WOULDN'T BE HAPPENING. PATIENT IS VERY UPSET. ONE OF THE INCISIONS HAS OPENED UP AND SCAR TISSUE WAS TAKEN OUT AND STITCHES WERE PLACED IN EYE. THIS HAS CAUSED PATIENT LONG TERM PROBLEMS. PATIENT HAS ADDITIONAL DETAILED INFO AND REPORTS IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND BLADE HNN UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other