BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 15957314 · Received December 12, 2022

    Report

    Report Number
    2518435-2022-00046
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    April 2, 2022
    Report Date
    April 29, 2023
    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

    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

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.10. THERE WAS NO SAMPLE RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAINED (MANUFACTURING) SAMPLE FOR THESE LOTS, SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT COULD BE ATTRIBUTED TO REPORTED EVENT. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT, SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED 10 OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR PFP CAUSING HIGH INTRAOCULAR PRESSURE SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2015. BASED UPON THE INFORMATION PROVIDED, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE 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).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT RECEIVED PERFLUORO PROPANE GAS AND EXPERIENCED MILD INTRAOCULAR HYPERTENSION IN THE RIGHT EYE AND RECEIVED MEDICINE TREATMENT FOR THE EVENT. THE PATIENT SYMPTOM WAS RESOLVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180522 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention