BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIPPER URINE DIPSTICK CONTROL

    MDR report key: 4898202 · Received July 6, 2015

    Report

    Report Number
    2020715-2015-00001
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 6, 2015
    Manufacturer
    QUANTIMETRIX CORPORATION
    Product Code
    CEK
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PER THE OFFICE MANAGER AT THE FACILITY - THE GLASS VIAL CONTAINING QUALITY CONTROL MATERIAL, DIPPER URINE DIPSTICK CONTROL BROKE IN THE MEDICAL ASSISTANT'S HAND WHEN SHE ATTEMPTED TO TWIST OFF THE CAP. THE CUT OCCURRED ON THE INDEX FINGER ON RIGHT HAND. THE OFFICE MANAGER MENTIONED THAT THE CUT WAS ADDRESSED BY A PHYSICIAN AND REQUIRED ONLY A BAND AID AND WAS CONSIDERED A LITTLE MINOR CUT. THE MEDICAL ASSISTANT WAS NOT WEARING GLOVES WHEN SHE ATTEMPTED TO TWIST OFF CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437474 DIPPER URINE DIPSTICK CONTROL URINALYSIS CONTROL, 862.1660 CEK QUANTIMETRIX CORPORATION 44822

    Patients

    Seq Age Sex Outcome Treatment
    1