BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1832381 · Received September 3, 2010

    Report

    Report Number
    1610287-2010-00112
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 08/05/2010 BY PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNKNOWN" (NO INFORMATION). PRODUCT PROBLEM(S): "MACULA NOT FLATTENING OUT AS IT SHOULD" (DEFECTIVE ITEM). A PURCHASING AGENT REPORTED THAT A GAS TANK HAD "QUALITY ISSUES". THE PURCHASING AGENT STATED A SURGEON REPORTED THE TANK WAS NOT PERFORMING AS IT SHOULD BECAUSE THE "MACULA IS NOT FLATTENING OUT AS IT SHOULD". THE PURCHASING AGENT REPORTED THE ISSUE HAD BEEN HAPPENING OVER A PERIOD OF TWO DAYS AND POSSIBLY TEN OR MORE PTS COULD BE INVOLVED. NO PT IDENTIFIERS ARE CURRENTLY AVAILABLE. ADD'L INFO HAS BEEN REQUESTED.

    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 817905

    Patients

    Seq Age Sex Outcome Treatment
    1