BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORID (SF6) GAS

    MDR report key: 3735717 · Received March 25, 2014

    Report

    Report Number
    1610287-2014-00037
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    December 19, 2013
    Report Date
    February 25, 2014
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THE GAS WAS GONE FROM THE EYE WITHIN A WEEKS TIME AFTER A VITRECTOMY SURGERY. A MIXTURE OF 20% SF6 AND 80% AIR HAD BEEN INJECTED INTO THE EYE. AS A RESULT THE MACULAR HOLE IN THIS EYE HAD TO BE OPERATED ON AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173606 ISPAN SULFUR HEXAFLUORID (SF6) GAS INTRAOCULAR AGS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 308410

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention