BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO REFLEX

    MDR report key: 12451891 · Received September 10, 2021

    Report

    Report Number
    3002806902-2021-00003
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 26, 2021
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000298
    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 PER THE INFORMATION PROVIDED BY THE IMPORTER ( ELLEX (B)(6)) , NO SAFETY ISSUES WERE REPORTED FOR THE DEVICE SINCE INSTALLATION. THE USER ADMITTED TO THE MISTAKE , THE 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 TANGO REFLEX MACHINE (TR1507) USED IN THE (B)(6)EYE CLINIC. THE COMPLAINANT WAS THE CLINICIAN AND THE REPORTED ADVERSE EVENT OCCURRED ON (B)(6) 20'21 REPORTED TO ELLEX (MANUFACTURER) VIA ELLEX (B)(6) ON 26TH AUGUST 2021. THE PATIENT DEVELOPED CATARACT AS A RESULT OF THE TREATMENT (VITREOLYSIS). THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349472 TANGO REFLEX OPHTHALMIC YAG LASER HQF ELLEX MEDICAL PTY LTD LT5106-T 09342395000298

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention