BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14490818 · Received May 24, 2022

    Report

    Report Number
    1610287-2022-00036
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 29, 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

    A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED THREE OTHER COMPLAINT AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR THIS EVENT, SHOWED NO COMPLAINTS. THE SAMPLE WAS NOT RETURNED, THEREFORE; TESTING COULD NOT BE PERFORMED. NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAINED SAMPLES FOR THIS LOT, SHOWED THAT THE PRODUCT MET ALL RELEASE CRITERIA. BASED UPON THE INFORMATION OBTAINED THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE 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).

    Description of Event or Problem · 0

    A CLINICAL STUDY REPORTED THAT AFTER USING PERFLUORO PROPANE GAS IN A SURGERY, A PATIENT EXPERIENCED HIGH INTRA-OCULAR PRESSURE (IOP). THE SEVERITY WAS MODERATE. MEDICAL TREATMENT WAS PROVIDED AND ALL THE SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488590 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention