BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 2094087 · Received May 6, 2011

    Report

    Report Number
    2518435-2011-00002
    Event Type
    Other
    Date Received
    May 6, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORP
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST LOT 023010. A CHECK OF THE BATCH PRODUCTION RECORD SHOWED NO UNUSUAL MANUFACTURING ISSUES. ANALYSIS OF A RESERVE SAMPLE BY GAS CHROMATOGRAPH (GC) SHOWED THAT THE PRODUCT MET PURITY SPECIFICATION AND THAT NO UNUSUAL PEAKS WERE SEEN. THIS REPORT MAILED IN TO THE FDA ON: (B)(4) 2011.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT STRONGER INFLAMMATION THAN USUAL WAS FOUND AFTER THE SURGERY. PT INFORMATION WAS NOT PROVIDED. THE NEED FOR INTERVENTION WAS NOT PROVIDED. THE PT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORP SF6, 125 G 023010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other