BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 2230715 · Received August 17, 2011

    Report

    Report Number
    1610287-2011-00094
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EVALUATION. REVIEW OF PRODUCT HISTORY RECORDS IS IN PROGRESS. THERE ARE TWO SIMILAR REPORTS FOR THIS LOT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED ON 07/18/2011 AND 07/19/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/01/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THREE PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING THE USE OF THIS PRODUCT MIXED TO 15% GAS. ON (B)(6) 2011, THE SURGEON REPORTED A PLANNED VITRECTOMY WAS PERFORMED ON (B)(6) 2011 TO CORRECT A RETINAL DETACHMENT. SHE STATED THE GAS EXPANDED IN THE EYE AND SHE FEELS THE CONTENTS OF THE GAS ARE NOT CORRECT. SHE REPORTED DROPS WERE USED TO LOWER THE PATIENT'S IOP AND THE PATIENT'S SYMPTOMS HAVE RESOLVED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 024208

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention