BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1956422 · Received January 7, 2011

    Report

    Report Number
    1610287-2011-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE COMPLAINT LOT HISTORY REVIEW REVEALED, THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT. ADDITIONAL INFO REQUESTED AND RECEIVED BY PHONE ON 01/05/2011. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED, THE PRODUCT'S VALVE WOULD NOT OPEN, CAUSING A 30 MINUTE DELAY IN CRYOPEXY SURGERY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 027313

    Patients

    Seq Age Sex Outcome Treatment
    1 NI