BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVU-QUICK ONE-STEP

    MDR report key: 492779 · Received October 20, 2003

    Report

    Report Number
    MW1029922
    Event Type
    Malfunction
    Date Received
    October 20, 2003
    Report Date
    October 20, 2003
    Manufacturer
    QUIDEL CORP
    Product Code
    NGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ONE OF THE PHYSICIANS (OB-GYN) STATED THAT TWO PTS HAD NON-OPERATIONAL OVUQUICK ONE-STEP NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVU-QUICK ONE-STEP OVULATION PREDICTOR NGE QUIDEL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *