BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14509256 · Received May 26, 2022

    Report

    Report Number
    1610287-2022-00037
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    February 10, 2022
    Report Date
    July 27, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    THE C3F8 [PERFLUOROPROPANE (PFP)] GAS TANK WAS NOT RETURNED FOR EVALUATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SEVEN OTHER COMPLAINTS AGAINST LOTS. NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FOR LOS, SHOWED THAT THE PRODUCT WAS PERFLUOROPROPANE (PFP) AND MET ALL RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. MANUFACTURE WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CLINICAL STUDY REPORT STATING THAT AFTER USING THE PERFLUOROPROPANE GAS THE PATIENT WAS EXPERIENCED WITH ELEVATED INTRAOCULAR PRESSURE . MEDICAL TREATMENT WAS PROVIDED AND SYMPTOMS WERE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030193 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R