BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPETTE,500 PER BOX,CYTYC

    MDR report key: 6131894 · Received November 29, 2016

    Report

    Report Number
    1216677-2016-00069
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 24, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    OHL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PER MEDWATCH UF IMPORTER REPORT NUMBER (B)(4). "EVENT DESC: THE CYTOBRUSH USED TO COLLECT PAP SMEAR SEPARATED UPON WITHDRAWAL FROM FEMALE PATIENT. THE CYTOBRUSH PORTION WAS THEN RETRIEVED FROM THE VAGINA USING A STERILE OB INSTRUMENT. THERE WAS SLIGHT BLEEDING SEEN IN POST VAGINAL WALL AND PATIENT WAS ADVISED SHE MAY HAVE SPOTTING." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784275 PAPETTE,500 PER BOX,CYTYC PAPETTE,500 PER BOX,CYTYC OHL COOPERSURGICAL, INC. 908006 166045

    Patients

    Seq Age Sex Outcome Treatment
    1