BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 21426369 · Received February 20, 2025

    Report

    Report Number
    0002518435-2025-00016
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    December 8, 2024
    Report Date
    February 14, 2025
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME LOT OF PERFLUOROPROPANE SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT. THIS IS A DUPLICATE OF MDR# (B)(4).

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME LOT OF PERFLUOROPROPANE SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE. THE PATIENT WAS GIVEN DRUG TREATMENT.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE. THE PATIENT WAS GIVEN DRUG TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096313 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 300502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R