BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECTCHECK QUALITY CONTROL

    MDR report key: 1562515 · Received December 17, 2009

    Report

    Report Number
    2248721-2009-00605
    Event Type
    Other
    Date Received
    December 17, 2009
    Date of Event
    November 6, 2009
    Report Date
    December 17, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED TO MFR. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLOOD EXPOSURE INCIDENT WHILE CRUSHING DIRECTCHECK QUALITY CONTROL VIAL. CUSTOMER REPORTS NOT USING PROTECTIVE SLEEVE REQUIRED FOR CORRECT PRODUCT HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECTCHECK QUALITY CONTROL NONE GGN INTERNATIONAL TECHNIDYNE CORP. DCJLR-A F9DLA034

    Patients

    Seq Age Sex Outcome Treatment
    1