BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2SU MICROKERATOME

    MDR report key: 11624512 · Received April 6, 2021

    Report

    Report Number
    9615659-2021-00004
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 6, 2021
    Product Code
    HMY
    PMA / PMN Number
    K022560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THEY HAD BUTTON HOLE DURING LASIK SURGERY. DISPOSABLE HEAD REF. 19334/130 WAS DISCARDED; SENDING M2 MOTORS REF. 19326 S/N (B)(4) AND (2) M2 RINGS REF. 19325/0 FOR EVALUATION. PATIENT IS SCHEDULED FOR PRK AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521667 M2SU MICROKERATOME M2SU MICROKERATOME HMY 19334/130 2191602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention