BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO

    MDR report key: 19482821 · Received June 7, 2024

    Report

    Report Number
    3002806902-2024-00002
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    October 1, 2023
    Report Date
    June 6, 2024
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K212630
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN USED BEFORE THE EVENT AND POST THE EVENT (CAVITY REPLACED FOR ENERGY STABILITY ISSUES IN (B)(6) 2024) WITH NO ISSUES. THE DEVICE PAF FROM (B)(6) 2024 DID NOT REPORT ANY COMPLAINTS/ REPAIRS APART FROM THE CAVITY.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SWEDEN, (B)(6) 2023 ON A TANGO (MANUFACTURED IN 2009) BUT REPORTED TO ELLEX ON 16TH MAY 2024. THE USER PERFORMED AN IRIDOTOMY PROCEDURE WHICH RESULTED IN REDUCED VISUAL ACUITY AND PERMANENT FOVEAL DAMAGE BILATERALLY. 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
    1260062 TANGO OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability