BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAPETTE

    MDR report key: 451801 · Received April 1, 2003

    Report

    Report Number
    MW1028041
    Event Type
    Other
    Date Received
    April 1, 2003
    Date of Event
    February 11, 2003
    Report Date
    March 27, 2003
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    HHT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PAP TEST ROUTINE, NO UTI OR VAGINAL YEAST INFECTIONS LAST 3 YEARS. EVENING AFTER PAP 1) INTERNAL DISCOMFORT, 2) A.M. PAINFUL LESIONS - SLIGHT BLEEDING, SWELLING, DISCOLORATION, 3) PEELING, 4) SWOLLEN LYMPH NODES WITH FLU LIKE SYMPTOMS, 5) YEAST INFECTION, 6) UTI CULTURED AND TREATED, 7) YEAST INFECTION, 8) CONTINUED DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAPETTE CERVICAL CELL COLLECTOR HHT WALLACH SURGICAL DEVICES, INC. REF 908006 10U1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other