BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 1321778 · Received February 20, 2009

    Report

    Report Number
    1610287-2009-00003
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 21, 2009
    Manufacturer
    ALCON - FORTH WORTH /ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED A LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE SURGEON INDICATED HE DID NOT FOLLOW THE DIRECTIONS FOR USE (DFU) AND THE PRODUCT USED IN THIS CASE HAD EXPIRED ONE YEAR PRIOR TO ITS USE (IN 2007). ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED PRODUCT WAS USED IN PATIENT'S EYES AS A TAMPONADE. HE REPORTED THE PRODUCT WAS MIXED: 8ML GAS WITHIN 50ML OF A NON-REFLATIONARY GAS (16% MIXTURE). IN THREE PATIENTS, THE GAS EXPANDED LEADING TO PAIN AND PRESSURE IN THE EYE. ONE PATIENT WAS HOSPITALIZED AND PRODUCT WAS DRAINED FROM THE EYE FIVE TIMES DURING THE NIGHT FOLLOWING SURGERY. THE OTHER TWO PATIENTS HAD PRODUCT DRAINED FROM THEIR EYE BUT THEY WERE NOT HOSPITALIZED. THE SURGEON REPORTED HE DID NOT FOLLOW THE DIRECTIONS FOR USE (DFU) AND HE USED AN EXPIRED PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE FIRST OF TWO MEDICAL DEVICE REPORTS BEING FILED; THIS REPORT IS FOR THE PATIENT THAT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORTH WORTH /ALCON LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R