BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER SUPER ABSORBENT TAMPON

    MDR report key: 64512 · Received January 21, 1997

    Report

    Report Number
    2529605-1997-00001
    Event Type
    Injury
    Date Received
    January 21, 1997
    Date of Event
    December 9, 1996
    Report Date
    January 20, 1997
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS BROUGHT INTO THE ER WITH NAUSEA, VOMITING, SORE THROAT, SKIN RASH, FEVER OF 104.2, AND COUGH PERSISTING FOR 48 HOURS. SHE WAS MENSTRUATING AND HAD BEEN USING SUPER ABSORBENT TAMPONS. SHE WAS ADMITTED AND DIAGNOSED WITH TOXIC SHOCK SYNDROME. SHE WAS TREATED WITH NAFCILLIN 2 GR Q6H AND IV HYDRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KROGER SUPER ABSORBENT TAMPON VAGINAL TAMPON HEB FIRST QUALITY HYGIENIC, INC. KROGER SUPER ABSORBENT UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R