BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPI-K MICROKERATOME

    MDR report key: 10864063 · Received November 18, 2020

    Report

    Report Number
    9615659-2020-00005
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    November 2, 2017
    Report Date
    November 10, 2020
    Manufacturer
    MORIA SA
    Product Code
    HNO
    PMA / PMN Number
    K043183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 NC2ATY & NC4ATY.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD 'STROMAL INCURSION' USING EPI-K MICROKERATOME. MORIA RECOMMENDED EPI-K SEPERATOR AND FULL SYSTEM BE SENT TO MORIA FOR EVALUATION. HEALTHCARE PROVIDER SENT IN EPI-K SEPERATOR REF. 19390 LOT 1110404 FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330106 EPI-K MICROKERATOME EPI-K MICROKERATOME HNO MORIA SA 19390 1110404

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other