BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN SULFUR HEXAFLUROIDE GAS

    MDR report key: 1321119 · Received February 20, 2009

    Report

    Report Number
    2518435-2009-00002
    Event Type
    Other
    Date Received
    February 20, 2009
    Report Date
    January 23, 2009
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED. THE EXPIRATION DATE OF THE GAS WAS REPORTED AS 2007. THIS REPORT MAILED TO THE FDA ON: (B)(4) 2009.

    Description of Event or Problem · 1

    NO PT INFORMATION WAS PROVIDED. THE PRODUCT IN QUESTION DEVICE WAS NOT RETURNED. THE EXPIRATION DATE WAS REPORTED AS 2007. NO OTHER PRODUCT INFORMATION WAS PROVIDED. THE PHYSICIAN REPORTED THAT THE PT PRESENTED WITH INCREASED INTRAOCULAR PRESSURE (IOP) IN CONJUNCTION WITH USE OF THE PRODUCT DURING SURGERY. IT WAS REPORTED THAT THE PRODUCT WAS USED AT 16% (LABELED DIRECTIONS ARE 100%.) INTERVENTION WAS REQUIRED TO REMOVE THE PRODUCT. THE PHYSICIAN DESCRIBED THE PT OUTCOME AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUROIDE GAS PRODUCT CODE LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 125 G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention