BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN TM SULFUR HEXAFLUORIDE GAS

    MDR report key: 1080217 · Received July 18, 2008

    Report

    Report Number
    2518435-2008-00006
    Event Type
    Other
    Date Received
    July 18, 2008
    Report Date
    June 20, 2008
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 COMPLAINTS RECEIVED FOR THIS LOT NUMBER. THIS REPORT MAILED TO THE FDA ON: 07/18/2008.

    Description of Event or Problem · 1

    FACILITY REPORTED PATIENT PRESENTED WITH INCREASED INTRAOCULAR PRESSURE. NO INFORMATION WAS PROVIDED ABOUT THE PROCEDURE. NO PATIENT IDENTIFIERS WERE PROVIDED. NO OUTCOME WAS PROVIDED FOR THE AFFECTED PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON 06/30/2008 AND 07/14/2008 BY PHONE AND E-MAIL. ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED AND THE QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM SULFUR HEXAFLUORIDE GAS PRODUCT CODE LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 450 G 725507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other