BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOTEX NATURAL CURVED TAMPONS

    MDR report key: 122335 · Received September 26, 1997

    Report

    Report Number
    2184163-1997-00002
    Event Type
    Death
    Date Received
    September 26, 1997
    Date of Event
    March 19, 1996
    Report Date
    September 26, 1997
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A LETTER DATED SEPTEMBER 8, 1997 WAS REC'D BY KIMBERLY-CLARK CORP ON OR ABOUT 9/12/1997, IN WHICH IT WAS REPORTED THAT THE PT DIED 28 DAYS AFTER BEING ADMITTED TO A HOSP WITH A DIAGNOSIS OF TOXIC SHOCK SYNDROME (TSS). IT WAS REPORTED THAT THE PT WAS IN THE THIRD DAY OF HER MENSTRUAL PERIOD, HAVING BEGAN MENSTRUATION ON MARCH 16, 1996, WHEN SEVERE FLU-LIKE SYMPTOMS WERE EXPERIENCED. THE LETTER STATES THAT SHE WAS USING SUPER ABSORBENCY TAMPONS AT THE TIME OF THE ONSET OF HER ILLLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX NATURAL CURVED TAMPONS MENSTRUAL TAMPON-SUPER ABSORBENCY HEB KIMBERLY-CLARK CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death