BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAMPAX PEARL TAMPONS, SCENTED

    MDR report key: 2191828 · Received December 14, 2005

    Report

    Report Number
    1523399-2005-00003
    Event Type
    Other
    Date Received
    December 14, 2005
    Date of Event
    March 27, 2005
    Report Date
    April 1, 2005
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    HIL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER'S DAUGHTER USED TAMPONS FROM 2 DIFFERENT PEARL PACKAGES, BUT JUST ONE BOX. DAUGHTER STARTED PERIOD ON FRIDAY, (B)(6). SHE USED THESE PEARLS, CHANGING TAMPONS EVERY 4 HOURS EXCEPT FOR OVERNIGHT. ON SUNDAY MORNING, SHE DEVELOPED A HIGH FEVER, HAD SEVERE VOMITING, FELT VERY WEAK. THE PEDIATRICIAN'S OFFICE RECOMMENDED THAT SHE BE TAKEN TO THE EMERGENCY ROOM. THEY TRANSFERRED HER TO (B)(6) HOSPITAL WHERE SHE WAS ADMITTED. THEY GAVE HER AN IV OF FLUIDS, CLINDAMYCIN AND VANCOMYCIN. SHE DEVELOPED RASH ON MONDAY MORNING. SHE WAS SENT HOME ON WEDNESDAY. SHE IS BETTER BUT STILL VERY WEAK. HER STOMACH HURTS TOO. SHE SAW SEVERAL DOCTORS IN THE HOSPITAL. SOME RECOMMENDED SHE NOT USE TAMPONS AND SOME RECOMMENDED SHE NOT USE TAMPONS UNTIL SHE IS 18. REPORTER FEELS PEARL TAMPONS CONTRIBUTED TO HER DAUGHTER'S TOXIC SHOCK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX PEARL TAMPONS, SCENTED MENSTRUAL TAMPONS, SCENTED HIL PROCTER & GAMBLE NA 4356414001

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization