BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPAX PEARL TAMPON, SUPER UNSCENTED (NOT APPLICABLE) TAMPON 1APPLIC

    MDR report key: 2050838 · Received April 1, 2011

    Report

    Report Number
    1219109-2011-00005
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 7, 2011
    Manufacturer
    TAMBRANDS MANUFACTURING, INC.
    Product Code
    HEB
    PMA / PMN Number
    K011996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS PROVIDED BY THE CONSUMER AND A LOT CHECK AND BATCH RETAIN TESTING WERE REQUESTED WITH RESULTS PENDING. A PRODUCT SAMPLE WAS NOT PROVIDED BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME (B)(6)]; INSTANTLY FELT REALLY SICK [MALAISE]; LIKE FLU SYMPTOMS [INFLUENZA LIKE ILLNESS]; FEVER 103 F [PYREXIA]; CHILLS [CHILLS]; VOMITING [VOMITING]; NAUSEA [NAUSEA]; DIARRHEA [DIARRHOEA]; EVERY TIME UPON GETTING UP WAS REALLY DIZZY [DIZZINESS POSTURAL]; PASSED OUT [LOSS OF CONSCIOUSNESS]; TOP NUMBER OF BLOOD PRESSURE WAS IN THE 40'S, DANGEROUSLY LOW [BLOOD PRESSURE SYSTOLIC DECREASED]; BLOOD PRESSURE LOW [HYPOTENSION]; KIDNEY DAMAGE [RENAL INJURY]; LIVER DAMAGE [LIVER INJURY]; DEHYDRATED [DEHYDRATION]; SUNBURN RASH ON LEGS [RASH ERYTHEMATOUS]; PEELING ON PALMS AND FEET [SKIN EXFOLIATION]; HAIR LOSS [ALOPECIA]; LEFT FOOT NUMB [PARAESTHESIA]; ANKLE STIFF [JOINT STIFFNESS]; TOES STIFF [MUSCULOSKELETAL STIFFNESS]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED (B)(4) TAMPON, VERSION/ABSORBENCY/SCENT UNK, UNSPECIFIED TOTAL DAILY USE, AND WAS HOSPITALIZED FOR EIGHT DAYS, INCLUDING NUMEROUS DAYS IN THE ICU, WITH TOXIC SHOCK SYNDROME IN (B)(6) 2010. SHE REPORTED THAT SHE WAS STILL IN THE PROCESS OF RECOVERY. TREATMENT: UNSPECIFIED HOSPITAL CARE AND TREATMENT. THE CASE OUTCOME WAS IMPROVED. OTHER PRODUCT USED PREVIOUSLY WITHOUT INCIDENT: YES, SHE HAS BEEN USING (B)(4) TAMPONS FOR SEVERAL YEARS. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2011, RECEIVED CONSUMER'S F/U PHONE CALL: THE CONSUMER REPORTED THAT SHE WAS ALLERGIC TO HYDROCODONE. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2011, SAFETY F/U PHONE CALL TO CONSUMER: THE CONSUMER, AGE (B)(6), HAD USED THE (B)(4) TAMPON, SUPER UNSCENTED FOR APPROX 15 HOURS INTO HER MENSTRUAL CYCLE WHEN SHE INSTANTLY FELT REALLY SICK WITH FLU LIKE SYMPTOMS INCLUDING FEVER, CHILLS, NAUSEA, AND DIARRHEA; SHE WAS REALLY DIZZY EVERY TIME SHE GOT UP AND ACTUALLY PASSED. HER ROOMMATE TOOK HER TO THE EMERGENCY ROOM WHERE THEY IMMEDIATELY NOTICED A SUNBURN TYPE RASH MOSTLY ON HER LEGS; A BLOOD PRESSURE READING REVEALED THE TOP NUMBER IN THE 40'S, DANGEROUSLY LOW, AND A FEVER OF 103 F. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010; THE TAMPON SHE WAS WEARING WAS REMOVED AND SHE WAS GIVEN MEDICINE TO IMPROVE HER BLOOD PRESSURE. SHE DEVELOPED A REACTION TO THE BLOOD PRESSURE MEDICATION AND HER LEFT FOOT BECAME REALLY NUMB AND SHE LOST ALL MOVEMENT OF HER LEFT FOOT FROM HER ANKLE DOWN. SHE STILL HAS THE NUMBNESS, HER ANKLE AND TOES ARE STIFF, BUT SHE CAN WALK ON IT AND SHE IS IN PHYSICAL THERAPY TRYING TO GET HER FOOT WORKING. SHE REPORTED THAT THEY WERE SAYING SHE HAD A (B)(6) INFECTION AND TREATMENT INCLUDED UNSPECIFIED IVS, ONE IN HER NECK, ONE IN HER LEFT HIP, AND ANTIBIOTICS BECAUSE HER KIDNEY AND LIVER WERE DAMAGED DUE TO DEHYDRATION. SHE HAD PEELING OF HER PALMS AND FEET, AND WAS NOW DEALING WITH HAIR LOSS AND HAS PURCHASED A WIG. THE CONSUMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010, AND HAS BEEN GOING TO THE DOCTOR FOR CHECK-UPS INCLUDING COMPLETE BLOOD COUNTS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX PEARL TAMPON, SUPER UNSCENTED (NOT APPLICABLE) TAMPON 1APPLIC NONE HEB TAMBRANDS MANUFACTURING, INC. 9060243043

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| O