BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14463204 · Received May 20, 2022

    Report

    Report Number
    1610287-2022-00030
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 12, 2024
    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

    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 ONE 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. 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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CLINICAL STUDY REPORTED THAT A PATIENT WAS ENROLLED IN THE STUDY FOR THE TREATMENT OF VISION OCCLUSION OF THE EYE FOR MORE THAN 10 DAYS. THE PATIENT UNDERWENT POSTERIOR VITRECTOMY (LEFT EYE) BY LASER PHOTOCOAGULATION OF RETINAL DETACHMENT REPAIRS, VITREOUS CAVITY GAS INJECTION, THE RETINA REPAIRS WITH VITREOUS GAS-LIQUID EXCHANGE TECHNIQUE, CRYOSEPHESIS OF THE RETINA, ABOVE MENTIONED METHODS ARE USED IN LEFT EYE SURGERY, USING PHOTOCOAGULATION COMBINED FROZEN SURGICAL METHOD FOR THE TREATMENT OF RETINAL DEGENERATION. DURING THE OPERATION, AIR WAS INJECTED INTO THE VITREOUS CAVITY, AND INTRAVITREAL OCTAFLUOROPROPANE GAS WAS INJECTED TO REPLACE THE AIR IN THE EYE. THE OPERATION WENT SMOOTHLY. IN THE POST-OPERATIVE EXAMINATION, RETINAL DETACHMENT WAS NOTED. THE PATIENT UNDERWENT VENTILATION THE LEFT EYE IN A LATERAL DECUBITUS POSITION FOR RETINAL DETACHMENT. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE OPHTHALMIC MEDICATIONS AND THE SYMPTOMS ARE RECOVERING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT ALL THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT ALL THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551347 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 034914 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Other| R