BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 15814952 · Received November 17, 2022

    Report

    Report Number
    2518435-2022-00025
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    January 8, 2022
    Report Date
    November 17, 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

    THIS REPORT ORIGINALLY FILED UNDER MFG REPORT NUM 1610287-2022-00040. ALL FUTURE REPORTS WILL BE SUBMITTED UNDER MFG REPORT NUM REFLECTED IN SECTION G.8 OF THIS REPORT. 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. A CHECK OF CONFIRMED COMPLAINTS FOR CORNEAL EPITHELIAL INJURY, CORNEAL EDEMA, OR OCULAR HYPERTENSION SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2015. NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FOR LOTS, SHOWED THAT THE PRODUCT WAS PERFLUOROPROPANE (PFP) AND MET ALL RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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 REPORT STATING THAT AFTER USING THE PERFLUOROPROPANE GAS THE PATIENT WAS EXPERIENCED WITH CORNEAL EPITHELIAL INJURY. MEDICAL TREATMENT WAS PROVIDED AND SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2786886 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O