BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 1762957 · Received June 30, 2010

    Report

    Report Number
    2250033-2010-00009
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NO PRODUCT RETURNED FROM USER FACILITY. RESULTS: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT IN A PROCESS OF RUNNING ACT+ LQC AND USING PLASTIC PROTECTIVE SLEEVE; SHARP INSTRUMENT CAME THROUGH SLEEVE AND GRAZED FINGER. CUSTOMER FLUSHED COPIOUSLY WITH WATER AND DISINFECTANT. CUSTOMER RECEIVED A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT CHECK QUALITY CONTROL DIRECT CHECK NORMAL ACT-LR GGN INTERNATIONAL TECHNIDYNE CORP. DCJACT-N K9DNA029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other