BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPAX RADIANT TAMPON, SUPER UNSCENTED

    MDR report key: 3373618 · Received September 5, 2013

    Report

    Report Number
    1219109-2013-00007
    Event Type
    Injury
    Date Received
    September 5, 2013
    Report Date
    August 16, 2013
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. THE CONSUMER DISCARDED THE PRODUCTS.

    Description of Event or Problem · 1

    TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME]. FEVER OF 100 [PYREXIA]. LIGHTHEADEDNESS [DIZZINESS]. VOMITING, DIARRHEA [DIARRHOEA]. MUSCLE SPASMS FROM LOWE ABDOMEN THAT RADIATED TO THE MIDDLE OF BACK [MUSCLE SPASMS]. HEADACHE, SHAKINESS [TREMOR]. VAGINAL RASH [VULVOVAGINAL RASH]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AT (B)(6), USED TAMPAX RADIANT TAMPON, SUPER UNSCENTED TAMPON CONCURRENTLY WITH TAMPAX RADIANT TAMPON, REGULAR UNSCENTED; ON AVERAGE 1 TAMPON EVERY HOUR FOR 7 DAYS. AFTER DAY 3 OF PRODUCT USE THE CONSUMER REPORTED SHE DEVELOPED A FEVER OF 100 DEGREES. SHE BECAME LIGHTHEADED, HAD VOMITING, DIARRHEA, HEADACHE, SHAKINESS, VAGINAL RASH AND MUSCLE SPASMS FROM LOWER ABDOMEN THAT RADIATED TO THE MIDDLE OF BACK. SHE TOOK OTC TYLENOL REGULAR STRENGTH PILLS ON MULTIPLE OCCASIONS AT HOME TO TREAT HER HEADACHE AND APPLIED A HEATING PAD TO HELP WITH MUSCLE SPASM. ON (B)(6) 2013, SHE WENT TO THE EMERGENCY DEPARTMENT BECAUSE HER SYMPTOMS BECAME WORSE AND WAS ADMITTED TO THE HOSPITAL. THE CONSUMER DISCONTINUED USE OF THE TAMPONS AND SWITCHED TO PADS. BLOOD TEST PERFORMED IN THE HOSPITAL CONFIRMED TOXIC SHOCK SYNDROME. X-RAYS AND CAT SCANS WERE PERFORMED AND HER KIDNEYS WERE MONITORED WHILE HOSPITALIZED. TREATMENT DURING HOSPITALIZATION INCLUDED: INTRAVENOUS FLUIDS, MULTIPLE ANTIBIOTIC SHOTS AND ORAL DRAMAMINE LIQUID. AFTER TWO WEEKS, THE CONSUMER WAS DISCHARGED FROM THE HOSPITAL WHEN THEY GAVE HER ANOTHER SHOT OF ANTIBIOTICS AND A BLOOD TEST THAT CONFIRMED THE TOXIC SHOCK INFECTION WAS GONE. THE CASE OUTCOME WAS RECOVERED. THE CONSUMER MENTIONED THAT SHE DISCARDED THE PRODUCT. PAST MEDICAL HISTORY INCLUDED: DRUG ALLERGY - CODEINE, MEDICAL HISTORY - CARDIAC VALVE DISEASE, CARDIAC PACEMAKER INSERTION, IMMUNE SYSTEM DISORDER. OTHER PRODUCT USED PREVIOUSLY: YES - USED TAMPAX SPORT TAMPONS SINCE (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441058 TAMPAX RADIANT TAMPON, SUPER UNSCENTED NONE HEB TAMBRANDS MANUFACTURING, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| O