BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPETTE

    MDR report key: 5913344 · Received August 30, 2016

    Report

    Report Number
    5913344
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 26, 2016
    Manufacturer
    WALLACH SURGICAL DEVICES INC
    Product Code
    MCO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564729 PAPETTE KIT, CERVICAL, SMEAR MCO WALLACH SURGICAL DEVICES INC 166045

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other NO.