BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRIGHT GIEMSA STAIN

    MDR report key: 2172001 · Received February 20, 2007

    Report

    Report Number
    3002805583-2007-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Report Date
    February 15, 2007
    Manufacturer
    VOLU-SOL, INC.
    Product Code
    GJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS THE FINAL LOT THAT CONTAINED THE ADDITIVE GLYCEROL AND FUTURE LOTS WILL NOT CONTAIN THE ADDITIVE.

    Description of Event or Problem · 1

    THE STABILIZER, GLYCEROL WAS ADDED TO ENHANCE THE BOLDNESS OF COLOR AND INCREASE CLARITY. THIS ENHANCED PRODUCT CAUSED WATER ARTIFACT ON RBC'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT GIEMSA STAIN WRIGHT GIEMSA STAIN GJH VOLU-SOL, INC. 616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention