BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2 MICROKERATOME

    MDR report key: 10856228 · Received November 17, 2020

    Report

    Report Number
    9615659-2020-00001
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    January 11, 2016
    Report Date
    November 9, 2020
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K002191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS THE RESULT OF A HISTORIC REVIEW BASED ON COMPANY INTERNAL CORRECTIVE & PREVENTIVE ACTION (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD BUTTON HOLE. PATIENT IS OK, SURGEON LAID DOWN FLAP AND WILL DO PRK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315086 M2 MICROKERATOME M2 MICROKERATOME HMY MORIA SA 19326 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other