BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 17692866 · Received September 6, 2023

    Report

    Report Number
    2518435-2023-00032
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    March 14, 2023
    Report Date
    June 12, 2024
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971022
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6 AND H.10. THERE WAS NO SAMPLE WAS RETURNED. THEREFORE, TESTING COULD NOT BE PERFORMED. AN ANALYSIS OF THE RETAIN SAMPLES LOTS SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CODE 4624 HAS BEEN UPDATED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CLINICAL STUDY STATED THAT HIGH INTRAOCULAR PRESSURE WAS HIGH IN RIGHT EYE BECAUSE OF POSSIBLE INCREASE IN INTRAOCULAR PRESSURE CAUSED BY GAS EXPANSION. PATIENT WAS PRESCRIBED WITH MEDICATION TO DECREASE IOP. SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858593 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 121407 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other| R