BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDIS CANNULA 27G8MM

    MDR report key: 1822546 · Received August 27, 2010

    Report

    Report Number
    2523835-2010-00090
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HMX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "VITRECTOMY" (VITRECTOMY). PRODUCT PROBLEM(S): "CANNULA BECAME DETACHED FROM THE SYRINGE" (DETACHMENT OF DEVICE OR DEVICE COMPONENT). THE CUSTOMER REPORTED THE HYDRODISECTION CANNULA BECAME DETACHED FROM THE SYRINGE, THE CANNULA FELL INTO THE EYE AND THE PT REQUIRED AN IMMEDIATE VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDIS CANNULA 27G8MM CANNULA, OPHTHALMIC HMX ALCON PRECISION DEVICE - SINKING SPRING 8065441620 797809M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention