BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 12444274 · Received September 9, 2021

    Report

    Report Number
    3002806902-2021-00002
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    September 1, 2017
    Report Date
    September 9, 2021
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WORKED TO SPECIFICATIONS AS VERIFIED BY THE PRODUCT ACCEPTANCE FAULT (PAF) RECORD BEFORE THE EVENT, AND THE SERVICING RECORDS POST THE EVENT ARE RELEVANT ONLY TO MAINTENANCE AND MINOR ADJUSTMENTS , NO SAFETY ISSUES WERE REPORTED. THERE WERE NO OTHER REPORTED ADVERSE EVENTS FOR THIS UNIT, THE POSSIBLE ROOT CAUSE OF THE INCIDENT WAS USER ERROR, A RESULT FROM INCORRECTLY TARGETING THE TREATMENT SITE. AN EVALUATION OF THE LABELING / DEVICE USABILITY WAS DONE, AND IT WAS DEEMED ADEQUATE.

    Description of Event or Problem · 1

    THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX MACHINE (UR0447) USED IN THE (B)(6) EYE CLINIC. THE COMPLAINANT WAS THE LAWYER AND THE REPORTED ADVERSE EVENT OCCURRED IN (B)(6) 2017 , REPORTED TO ELLEX MEDICAL (MANUFACTURER) VIA ELLEX (B)(6) OFFICE ON (B)(6) 2021. THE PATIENT CLAIMS TO HAVE DEVELOPED CATARACTS, THE DAY AFTER TREATMENT, DUE TO THE EFFECT ON THE CRYSTALLINE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343173 ULTRA Q REFLEX OPHTHALMIC YAG LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention