BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREEN'S

    MDR report key: 356220 · Received October 16, 2001

    Report

    Report Number
    2529605-2001-00009
    Event Type
    Injury
    Date Received
    October 16, 2001
    Date of Event
    August 4, 2001
    Report Date
    October 1, 2001
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REC'D BY FIRST QUALITY HYGENIC, INC. (FQH) FROM PLAYTEX ON 2001 AFTER IT WAS DETERMINED BY PLAYTEX THAT THE MFR OF THE PRODUCT WAS FQH. THE FOLLOWING INFO WAS TAKEN FROM THE COMPLAINT FILE INITIATED BY PLAYTEX AND FORWARDED TO FQH. "CONSUMER HAD NOT USED TAMPONS IN SEVERAL YEARS, BUT PURCHASED THESE BECAUSE CONSUMER WAS GOING ON A LONG CAR TRIP. CONSUMER USED FROM WEDS THROUGH SUN, STARTED TO EXPERIENCE CRAMPS, THE NEXT DAY. AT FIRST CONSUMER THOUGHT IT WAS GAS OR NORMAL CRAMPS UNTIL COMSUMER HAD A FEVER, CONSUMER WENT TO EMERGENCY ROOM AND FEVER WAS 103. THEY GAVE CONSUMER IV TO BRAKE FEVER. DR DID A PAP SMEAR AND DETECTED THAT THERE WAS AN INFECTION, AND ADMITTED CONSUMER TO A HOSPITAL, WHERE CONSUMER STAYED FOR 4 DAYS. CONSUMER IS FEELING A LITTLE BETTER NOW, THE RECUPERATION PERIOD HAS CONSUMER IN LIMITED ACTIVITIES. THEY RULED OUT OTHER POSSIBILITIES AND ARE CERTAIN IT IS FROM THE TAMPON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46453 WALGREEN'S MENSTRUAL TAMPON HEB FIRST QUALITY HYGIENIC, INC. SUPER 99JSC09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization