BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1829970 · Received September 2, 2010

    Report

    Report Number
    2518435-2010-00011
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 5, 2010
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT BY GAS CHROMATOGRAPH (GC) SHOWED THAT THE PRODUCT MET PURITY SPECIFICATION AND THAT NO UNUSUAL PEAKS WERE SEEN COMPARED TO THE ORIGINAL GC. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED THAT THE ORIGINAL GC ANALYSIS MET PURITY SPECIFICATION. THERE HAVE BEEN NO OTHER REPORTS INVOLVING THIS LOT NUMBER. NO CONCLUSION CAN BE DRAWN. THIS REPORT MAILED IN TO THE FDA ON: (B)(4) 2010.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT INTRAOCULAR SF6 DID NOT "FLATTEN OUT THE MACULAR AS IT SHOULD." THE NUMBER OF PATIENTS AFFECTED WAS NOT PROVIDED. THE DATES OF THE EVENTS WERE NOT PROVIDED. NO PATIENT IDENTIFIERS WERE PROVIDED. NO PATIENT OUTCOMES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 125 G 817905

    Patients

    Seq Age Sex Outcome Treatment
    1