BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14491027 · Received May 24, 2022

    Report

    Report Number
    1610287-2022-00035
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    January 27, 2022
    Report Date
    July 12, 2022
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971053
    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 COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. A CHECK OF THE COMPLAINT RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A CHECK OF CONFIRMED COMPLAINTS FOR THIS EVENT, SHOWED NO COMPLAINTS. THE SAMPLE WAS NOT RETURNED, THEREFORE; TESTING COULD NOT BE PERFORMED. THERE WAS NO ADDITIONAL RELATED INFORMATION PROVIDED, THE CUSTOMERS¿ REPORTED EVENT WAS NOT CONFIRMED. 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 PHYSICIAN REPORTED THAT DURING A SURGERY HIGH INTRAOCULAR PRESSURE WAS OBSERVED WITH AN OPHTHALMIC GAS. THE EVENT AS RESOLVED AFTER MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219513 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657971053

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R