BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXALFUORIDE (SF6) GAS

    MDR report key: 3807552 · Received March 19, 2014

    Report

    Report Number
    1610287-2014-00029
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE GAS DISSIPATED AFTER 10 DAYS BUT SHOULD HAVE LASTED LONGER. INITIALLY, THE BUBBLE WAS THE SIZE IT SHOULD HAVE BEEN AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163972 ISPAN SULFUR HEXALFUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION VISION SYSTEM