BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER SUPER ABSORBENT TAMPONS

    MDR report key: 58407 · Received December 27, 1996

    Report

    Report Number
    58407
    Event Type
    Injury
    Date Received
    December 27, 1996
    Date of Event
    December 9, 1996
    Report Date
    December 17, 1996
    Manufacturer
    1ST QUALITY HYGENIC FOR KROGER
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS BROUGHT INTO ER WITH NAUSEA, VOMITING, SORE THROAT, SKIN RASH, FEVER OF 104.2, AND COUGH PERSISTING FOR 48 HRS. 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 TAMPONS VAGINAL TAMPON HEB 1ST QUALITY HYGENIC FOR KROGER UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R