BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN GAS (UNK)

    MDR report key: 1438636 · Received August 11, 2009

    Report

    Report Number
    2518435-2009-00007
    Event Type
    Injury
    Date Received
    August 11, 2009
    Date of Event
    January 1, 2007
    Report Date
    July 23, 2009
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORP
    Product Code
    LPO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. BATCH PRODUCTION RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO MANUFACTURING DOCUMENTATION. THE PACKAGE INSERT STATES, "SEVERE ELEVATED IOP THAT HAS BEEN KNOWN TO RESULT IN VISION DECREASE AND BLINDNESS IF NITROUS OXIDE IS ADMINISTERED DURING A SUBSEQUENT SURGICAL OR DENTAL PROCEDURE WITH A GAS BUBBLE PRESENT IN THE EYE." IT ALSO STATES, "FOLLOWING USE OF THIS PRODUCT AND PRIOR TO DISCHARGE, WARN THE PATIENT OF THE FOLLOWING INFORMATION PRESENT ON THE PATIENT WARNING CARD AND BRACELET." THIS PATIENT WAS REPORTED TO HAVE BEEN WEARING THE APPROPRIATE WARNING BRACELET AT THE TIME OF THE SUBSEQUENT PROCEDURE WHERE NITROUS OXIDE WAS USED AND INCREASED IOP WAS EXPERIENCED.

    Description of Event or Problem · 1

    A FACILITY DIRECTOR REPORTED A PATIENT EXPERIENCED INCREASED INTRAOCULAR PRESSURE (IOP) FOLLOWING EXPOSURE TO NITROUS OXIDE GAS DURING A NON-OPHTHALMIC PROCEDURE (KIDNEY STONES REMOVED) AFTER HAVING THIS PRODUCT USED IN A PREVIOUS OCULAR SURGICAL PROCEDURE. THE PATIENT'S INCREASED IOP WAS TREATED WITH TOPICAL DROP THERAPY AND AN INTRAVITREAL TAP. INCREASED IOP RESOLVED FOLLOWING TREATMENT. THE FACILITY REPORTED THAT PATIENT WAS WEARING THE APPROPRIATE WRISTBAND ALERT; HOWEVER, IT WAS NOT SEEN BY THE HEALTHCARE PROVIDERS PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN GAS (UNK) LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention