BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN

    MDR report key: 1039034 · Received April 30, 2008

    Report

    Report Number
    2518435-2008-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    February 18, 2008
    Report Date
    April 4, 2008
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT BY GAS CHROMATOGRAPH (GC) SHOWED THAT THE PRODUCT MET PURITY SPECIFICATION AND THAT NO UNUSUAL PEAKS WERE SEEN COMPARED TO THE ORIGINAL GC ANALYSIS. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED THAT THE ORIGINAL GC ANALYSIS MET PURITY SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. NO CONCLUSION CAN BE DRAWN. THIS REPORT MAILED IN TO THE FDA ON: 04/30/2008.

    Description of Event or Problem · 1

    NURSE REPORTS FOR SURGEON THAT GAS BUBBLE DID NOT LAST LONGER THAN A WEEK ALLOWING RETINA TO RE-DETACH. THE SURGEON INDICATED THAT THE SF6 BUBBLE DISSIPATED FASTER THAN IT SHOULD HAVE. FIRST PROCEDURE: SCLERAL BUCKLE, EXTERNAL DRAINS FOR SUBRETINAL FLUID, PARS PLANA VITRECTOMY, FLUID AIR EXCHANGE, ENDOLASER PHOTOCOAGULATION AND INJECTION OF 30% SF6 GAS IN RIGHT EYE PERFORMED IN 2008. THE SF6 WAS DILUTED WITH AIR TO A CONCENTRATION OF 30%. DILUTION OF THE SF6 GAS WITH AIR IS AN OFF-LABEL USE. SECOND PROCEDURE WAS PERFORMED TEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN RETINAL STABILIZING ADJUNCT LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 450 G 623308

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR