BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 2077930 · Received April 1, 2011

    Report

    Report Number
    2518435-2011-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO CONCLUSION CAN BE DRAWN. THIS REPORT MAILED IN TO THE FDA ON: (B)(4) 2011.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE GAS IS BEHAVING DIFFERENTLY THAN USUAL. HE STATED THAT IT IS REMAINING IN THE EYE FOR A SHORTER TIME. HE REPORTED THAT THERE WAS NO PATIENT HARM. NO PATIENT IDENTIFIERS WERE PROVIDED. THE LOT NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION C3F8, 125 G

    Patients

    Seq Age Sex Outcome Treatment
    1