BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 2102081 · Received April 14, 2011

    Report

    Report Number
    2250033-2011-00011
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    April 4, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: NO PRODUCT RETURNED. RESULTS: PRODUCT MET ALL RELEASE CRITERIA. CONCLUSIONS: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. THE DIRECTCHECK PROTECTIVE SLEEVE IS PROVIDED AS A MEANS TO REDUCE PROBABILITY OF CUTS. THE INSTRUCTIONS FOR USE INDICATES USE OF PROTECTIVE SLEEVE IS REQUIRED WHEN CONTROL VIALS ARE ACTIVATED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS CUTTING FINGER ON DIRECT CHECK QUALITY CONTROL. IT IS UNKNOWN IF THE PROTECTIVE SLEEVE WAS IN USE AT THE TIME OF THE INCIDENT. NO REPORT OF SERIOUS INJURY, OR ADMINISTRATION OF MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT CHECK QUALITY CONTROL GGN INTERNATIONAL TECHNIDYNE CORPORATION DCJACT-N

    Patients

    Seq Age Sex Outcome Treatment
    1