BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 4260899 · Received November 15, 2014

    Report

    Report Number
    1610287-2014-00071
    Event Type
    Malfunction
    Date Received
    November 15, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED AND CONFIRMED TO NOT BE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL MANAGER REPORTED THAT THE GAS BUBBLE INSTILLED DURING THREE SEPARATE PNEUMATIC RETINOPEXY PROCEDURES ONLY LASTED FOR ONE TO TWO DAYS IN DURATION. PATIENT IMPACT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED. ADDITIONAL INFO WAS RECEIVED BY THE REPORTER WHO CLARIFIED THAT THERE WAS NO IMPACT TO ANY PATIENT AS A RESULT OF THE BUBBLES' SHORT DURATION TIME. NO FURTHER PATIENT OR EVENT INFO CAN BE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740794 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 407116

    Patients

    Seq Age Sex Outcome Treatment
    1