BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 3632122 · Received February 3, 2014

    Report

    Report Number
    1610287-2014-00001
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 7, 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 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPERATING ROOM TEAMLEADER REPORTED THAT THE EFFECT OF GAS USED DURING TWO SURGERIES WAS NOT GOOD AS IT DID NOT TAMPONADE UPON THE RETINA. BOTH PATIENTS WERE TREATED AGAIN WITH UNKNOWN PATIENT OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71271 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 308410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention