BEUDAMED
    FDA Adverse Event Summary report: N

    TAMPAX, SUPER

    MDR report key: 11373 · Received February 8, 1994

    Report

    Report Number
    MW1000682
    Date Received
    February 8, 1994
    Date of Event
    June 28, 1993
    Report Date
    February 8, 1994
    Manufacturer
    TAMBRANDS, INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR DEVELOPED TOXIC SHOCK SYNDROME WHILE USING THIS PRODUCT. THE RPTR EXPERIENCED VIOLENT CHILLS, VOMITING, DIARRHEA, HYPOTENSION (50/0), SWELLING OF THE BODY, HALLUCINATIONS AND KIDNEY FAILURE. THE RPTR WAS HOSPITALIZED FOR FIVE DAYS. AFTER DISCHARGE FROM THE HOSP, THE RPTR EXPERIENCED LOSS OF HAIR AND FINGERNAILS, SKIN PEELING AND MEMORY LOSS. THE RPTR STATED THAT INCIDENT OCCURRED ON THE SECOND OR THIRD DAY OF HER PERIOD. SHE FURTHER STATED THAT SHE CHANGED THE PRODUCT EVERY FEW HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX, SUPER HEB TAMBRANDS, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 *