BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 2113646 · Received June 1, 2011

    Report

    Report Number
    1610287-2011-00064
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 2, 2011
    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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT REC'D FOR EVAL. IT IS UNK IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. REVIEW OF LOT 034004 IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED VIA PHONE ON 04/04/2011, 04/05/2011, 04/29/2011, AND 05/02/2011, 05/04/2011; VIA MAIL ON 04/05/2011. A COMPLETED QUESTIONNAIRE WAS REC'D ON 05/02/2011 AND ADD'L INFO WAS REQUESTED VIA PHONE ON 05/04/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE BLACK KNOB ON A (B)(4) TANK WOULD NOT TURN. SHE STATED THEY SWITCHED FROM THE (B)(4) TO THIS PRODUCT AND THERE WAS A DELAY IN THE PROCEDURE OF AT LEAST 15 MINUTES. SHE STATED ON (B)(6) 2011 THE PT RETURNED FOR A REPEAT PROCEDURE DUE TO THIS GAS DID NOT EFFECTIVELY PRESS DOWN THE MACULAR HOLE. SHE STATED THE SUBSEQUENT PROCEDURE WAS PERFORMED WITH (B)(4) GAS AND SHE WAS UNSURE OF THE PT STATUS. SHE REPORTED THE FACILITY IS NOT BLAMING THIS PRODUCT RATHER IT WAS NOT THE IDEAL CHOICE FOR THIS PT'S PROCEDURE. ADD'L INFO WAS REQUESTED. THIS IS THE SECOND MEDICAL DEVICE REPORT BEING FILED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 034004

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention