BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN PERFLUOROPROPANE GAS

    MDR report key: 1271519 · Received December 22, 2008

    Report

    Report Number
    2518435-2008-00009
    Event Type
    Other
    Date Received
    December 22, 2008
    Report Date
    November 24, 2008
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORP
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE CYLINDER WAS RETURNED TO FACILITY 2008. THE CYLINDER WAS FOUND TO BE EMPTY. THE RETAINED CYLINDER FOR THE MASTER LOT (635502) USED TO TRANSFILL LOT 713521 WAS ANALYZED FOR AIR, PERFLUOROPROPANE ID AND OVERALL PURITY. ALL RESULTS WERE FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED NO PROCESS OR ANALYSIS ISSUES. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THE LOT NUMBER. THIS REPORT MAILED TO THE FDA ON: 12/22/08.

    Description of Event or Problem · 1

    FACILITY REPORTED PT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP) IN CONJUNCTION WITH THE USE OF C3F8 ISPAN. IT WAS REPORTED THE PRODUCT HAD BEEN USED AT 14% (DILUTED WITH AIR). WE HAVE NO ADD'L INFO ABOUT THE ELEVATED IOP AT THIS TIME. WE HAVE REQUESTED ADD'L INFO AND WILL UPDATE THE MDR WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE GAS LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORP C3F8, 450 G 713521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other