BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 3815760 · Received March 26, 2014

    Report

    Report Number
    1610287-2014-00040
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    ALCON - FORT WITH / ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A GAS BUBBLE WAS DRASTICALLY SMALLER AT ONE DAY POST OP. PT IMPACT IS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176797 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO ALCON - FORT WITH / ALCON LABORATORIES, INC. NA 231122

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR