BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAPETTE

    MDR report key: 526252 · Received May 4, 2004

    Report

    Report Number
    MW1032003
    Event Type
    Other
    Date Received
    May 4, 2004
    Date of Event
    April 28, 2004
    Report Date
    May 4, 2004
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    HFE
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE IS USED TO COLLECT ECTOCERVICAL AND ENDOCERVICAL CELL SAMPLES FROM FEMALE PTS. IT LOOKS LIKE A SMALL BRUSH AT THE END OF A STICK-LIKE HANDLE. THIS BRUSH COMPONENT WAS RETAINED IN THE PT'S VAGINA UNTIL IT WAS RETRIEVED BY THE PHYSICIAN VIA BAYONETTE FORCEPS. FORTUNATELY NO INJURY WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAPETTE CERVICAL BRUSH HFE WALLACH SURGICAL DEVICES, INC. REF 908006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other