BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 17787110 · Received September 21, 2023

    Report

    Report Number
    2518435-2023-00036
    Event Type
    Injury
    Date Received
    September 21, 2023
    Report Date
    December 18, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657970056
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PRODUCT IDENTIFIERS (SERIAL NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. THE SERIAL IS UNKNOWN. THEREFORE, A SERVICE HISTORY REVIEW CANNOT BE PERFORMED. BASED UPON THE INFORMATION PROVIDED, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. 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

    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).

    Description of Event or Problem · 0

    THE INVESTIGATOR REPORTED IN A ABSTRACT AFTER USING SULFUR HEXAFLUORIDE (SF6) GAS TAMPONADE ON PATIENTS OPERATED FOR UNILATERAL LAMELLAR MACULAR HOLE (LMH). SOME PATIENTS EXPERIENCED POOR FINAL BEST-CORRECTED VISUAL ACUITY (BCVA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446169 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657970056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other