BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 7013246 · Received November 9, 2017

    Report

    Report Number
    1610287-2017-00071
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 23, 2017
    Report Date
    March 9, 2018
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION IS NOT ANTICIPATED FOR THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE OPHTHALMIC SULFUR HEXAFLUORIDE GAS DIRECTIONS FOR USE (DFU) INCLUDE CAUTIONS REGARDING OPERATIVE COMPLICATIONS AND POSTOPERATIVE COMPLICATIONS THAT MAY POTENTIALLY OCCUR. THE PRECAUTIONS NOTE CAUTION SHOULD BE USED IN EYES WITH ANGLE RECESSION, PIGMENT DISPERSION SYNDROME, SIGNIFICANT ANTERIOR SYNECHIAE, TRAUMATIZED EYES AND EYES WITH SIGNIFICANT VITREOUS HEMORRHAGE OBSCURING AN ADEQUATE VIEW OF THE PERIPHERAL RETINA. THE PATIENT MUST RECEIVE A PATIENT WARNING CARD AND BRACELET TO ADVISE ANY HEALTH CARE PROVIDER ABOUT POSSIBLE LOSS OF VISION OR BLINDNESS IF NITROUS OXIDE ANESTHESIA IS ADMINISTERED WITH A GAS BUBBLE PRESENT IN THE EYE. THE PATIENT IS CAUTIONED NOT TO TRAVEL BY PLANE, THROUGH HIGH ELEVATIONS OR OVER MOUNTAIN RANGES UNTIL THE GAS BUBBLE HAS DISSIPATED. THE PATIENT MUST MAINTAIN PROPER HEAD POSITIONING FOLLOWING EYE SURGERY. INCORRECT HEAD POSITIONING MAY CAUSE THE SURGERY TO BE UNSUCCESSFUL, OR MAY CAUSE GLAUCOMA, AND/OR MAY CAUSE CATARACTS. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THE DESIGN OR PERFORMANCE OF THE OPHTHALMIC SULFUR HEXAFLUORIDE GAS CONTRIBUTED TO THE EVENT REPORTED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT OPHTHALMIC GAS THAT WAS INSTILLED INTO A PATIENT'S EYE WAS NOTED UPON FOLLOW UP SLIT LAMP EXAM TO HAVE REACHED TO THE BACK OF THE SUPRACHOROID. THE PATIENT EXPERIENCED A SUPRACHOROIDAL DETACHMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED FURTHER CLARIFIED THAT CAUSALITY WITH THE PRODUCT WAS DENIED BY THE DOCTOR WHO IS NOT BLAMING THE PRODUCT RATHER, THIS IS AN EVENT THAT OCCURRED IN CONJUNCTION WITH PRODUCT USE. ADDITIONAL INFORMATION IS NOT ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791914 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other