BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAGEN

    MDR report key: 1474767 · Received June 25, 2009

    Report

    Report Number
    1216677-2009-00017
    Event Type
    Malfunction
    Date Received
    June 25, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 25, 2009
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFE
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT DATABASE WAS CONDUCTED WITH NO SIMILARLY REPORTED COMPLAINTS FOR THIS PRODUCT. A DHR REVIEW WAS CONDUCTED ON THE 2 BRUSH LOTS USED IN LOT 71504 WITH NO ANOMALIES OR DEVIATIONS NOTED. TORQUE TESTS DATA WERE REVIEWED WITH ACCEPTABLE RESULTS. A DHR REVIEW WAS CONDUCTED ON LOT 71504 WITH NO DEVIATION OR ANOMALIES NOTED. (B)(4). (B)(4).

    Description of Event or Problem · 1

    DURING A CERVICAL SAMPLE, THE BRUSH HEAD SEPARATED FROM THE HANDLE. THE BRUSH HEAD WAS REMOVED MANUALLY (FINGERS OR FORCEPS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QIAGEN DNA COLLECTION DEVICE HFE COOPERSURGICAL, INC. 5126-1220 71504

    Patients

    Seq Age Sex Outcome Treatment
    1