BEUDAMED
    FDA Adverse Event Other Summary report: N

    8031673-2008-00001

    MDR report key: 1138803 · Received August 18, 2008

    Report

    Report Number
    8031673-2008-00001
    Event Type
    Other
    Date Received
    August 18, 2008
    Product Code
    JJE
    PMA / PMN Number
    K971103
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS THE RESULT OF IMPROPER MIXING OF THE WASH SOLUTION BY THE USER FACILITY. THE USER FACILITY MADE THE WASH SOLUTION WITH ONE BOTTLE OF CONCENTRATE PER 5L OF DISTILLED WATER INSTEAD OF THE CORRECT MIXTURE OF 2 CONCENTRATES TO 5L OF DISTILLED WATER. NO MEDICAL INTERVENTION BY A HEALTHCARE PROFESSIONAL WAS REPORTED TO TOSOH BIOSCIENCE, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JJE

    Patients

    Seq Age Sex Outcome Treatment
    1