BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1960999 · Received January 11, 2011

    Report

    Report Number
    1219109-2011-00001
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 17, 2010
    Manufacturer
    TAMBRANDS MANUFACTURING, INC.
    Product Code
    HEB
    PMA / PMN Number
    K061486
    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, REPORTER HAS DISCARDED THE PRODUCT.

    Description of Event or Problem · 1

    TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME STREPTOCOCCAL]. SPIKED A FEVER OF 104.5 [PYREXIA]. BREATHING DIFFICULTY, FELT LIKE COULDN'T BREATHE, SHORTNESS OF BREATH [DYSPNOEA]. BLOOD PRESSURE KEPT DROPPING, HAD BLOOD PRESSURE OF 65/32 [BLOOD PRESSURE DECREASED]. GOT THE CHILLS [CHILLS]. REALLY HORRIBLE HEADACHE [HEADACHE]. BAD STOMACH LIKE WEIRD PAINS IN ABDOMEN [ABDOMINAL PAIN]. LAID ON COUCH, COULD NOT EVEN FUNCTION-WEAK [ASTHENIA]. BACK HURT SO BAD [BACK PAIN]. COULD NOT WALK [GAIT DISTURBANCE]. SEPTIC [SEPSIS]. WHITE BLOOD CELL COUNT WAS SO HIGH [WHITE BLOOD CELL COUNT INCREASED] SEVERELY ANEMIC [ANAEMIA]. INFUSION TO HELP BLOOD CLOT [COAGULOPATHY]. STOMACH KEPT EXTENDING, STOMACH WAS HUGE [ABDOMINAL DISTENSION]. HUGE POCKETS OF FLUIDS IN STOMACH [ASCITES]. FLUID AROUND LUNGS [PLEURAL EFFUSION]. OXYGEN LEVEL WAS SO LOW [OXYGEN SATURATION DECREASED]. INCISIONAL PAIN [INCISION SITE PAIN]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE, AGE (B)(6), USED THE TAMPAX UNSCENTED TAMPON, ABSORBENCY UNK, UNSPECIFIED TOTAL DAILY USE, AND WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR SIX DAYS AND ON A BREATHING VENTILATOR FOR TWO DAYS AFTER SHE DEVELOPED TOXIC SHOCK SYNDROME AND ALMOST DIED. SHE REPORTED THAT SHE ALL OF A SUDDEN GOT THE CHILLS, DEVELOPED A HORRIBLE HEADACHE, AND FELT LIKE SHE COULD NOT BREATHE. SHE WENT TO THE DOCTOR AND WHILE SHE WAS THERE, HER BLOOD PRESSURE KEPT DROPPING. SHE SPIKED A FEVER OF 104.5 AND DEVELOPED WEIRD PAINS IN HER ABDOMEN; THE DOCTOR RAN A COUPLE OF TESTS, TOLD HER IT COULD NOT BE ANYTHING MAJOR AN SENT HER HOME. AT HOME SHE COULD NOT BREATHE, HAD SHORTNESS OF BREATH, AND A REALLY HORRIBLE HEADACHE, AND SHE PRETTY MUCH JUST LAID ON THE COUCH AND DIDN'T MOVE. WHEN SHE AWOKE THE NEXT DAY, SHE COULD NOT EVEN FUNCTION AND HAD TO CALL AN AMBULANCE. HER BLOOD PRESSURE KEPT DROPPING AND WAS 65/32 WHEN SHE ARRIVED AT THE HOSPITAL. SHE WAS GIVEN 4 BLOOD TRANSFUSIONS, 2 PLASMA TRANSFUSIONS, AND THEN SURGERY TO CLEAN HER OUT AND PUT ANTIBIOTICS IN HER STOMACH. SHE MENTIONED THAT THEY WEREN'T SURE SHE WAS EVEN GOING TO COME OUT OF THE SURGERY. THE CASE OUTCOME WAS UNK. PAST MEDICAL HISTORY INCLUDED: HIST DRUG/PREV EXP - EXPERIENCED A MILD HEADACHE WHEN USING TAMPONS WITH A CARDBOARD APPLICATOR EIGHTEEN MONTHS AGO, MEDICAL HISTORY - HAS HAD FOUR CHILDREN. OTHER PRODUCT USED PREVIOUSLY WITHOUT INCIDENT: YES - NORMALLY USED THE TAMPAX PEARL. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2010, RECEIVED CONSUMER'S FOLLOW-UP PHONE CALL: THE CONSUMER REPORTED THAT SHE THOUGHT, THE TAMPONS WERE SUPER PLUS AND SHE HAD BEEN USING THEM FOR A FEW DAYS BEFORE THE SYMPTOMS BEGAN. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, AND HAD A SURGERY THAT INVOLVED A CUT FROM NEAR HER CERVICAL BONE TO HER CHEST TO PUT ANTIBIOTICS IN HER STOMACH. WHILE HOSPITALIZED FOR TWO WEEKS, SHE WAS GIVEN ANTIBIOTICS BY IV AND AT DISCHARGE WAS GIVEN ANTIBIOTIC PILLS TO TAKE WHEN SHE ARRIVED HOME. SHE REPORTED THAT HER DOCTOR TOLD HER SHE CAN NO LONGER USE TAMPONS. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2010 SAFETY FOLLOW-UP PHONE CALL TO CONSUMER. THE CONSUMER REPORTED THAT SHE HAD USED THE TAMPONS FOR 3 DAYS, CHANGING FREQUENTLY BECAUSE, SHE FLOWS VERY HEAVILY, AND THE SYMPTOMS DEVELOPED ON THE 4TH DAY OF HER MENSTRUAL CYCLE, ON (B)(6) 2010. SHE WAS AT THE EMERGENCY ROOM FROM 16:00 ON (B)(6) 2010 UNTIL 01:30 ON (B)(6) 2010 AND TESTS INCLUDED A CT SCAN FOR ABDOMINAL PAIN AND A BLOOD TEST; HER BLOOD PRESSURE KEPT DROPPING BUT A DIFFERENT CUFF GAVE A READING OF 83 OVER SOMETHING; THE DOCTOR TOLD HER SHE WAS SEPTIC AND SENT HER HOME WITH IBUPROFEN. THE CONSUMER CALLED THE AMBULANCE AT 20:00 ON (B)(6) 2010 BECAUSE, SHE COULDN'T BREATH, COULDN'T WALK, HER STOMACH HURT SO BAD AND HER BACK HURT. SHE WAS TRANSPORTED TO ANOTHER EMERGENCY ROOM WHERE SHE WAS GIVEN FOUR BLOOD TRANSFUSION BECAUSE, SHE WAS SEVERELY ANEMIC AND HER WHITE BLOOD CELL COUNT WAS SO HIGH, AND TWO BAGS OF PLASMA TO HELP BLOOD CLOT. SHE WAS ADMITTED TO THE HOSPITAL INTENSIVE CARE UNIT THAT NIGHT, PUT ON OXYGEN BECAUSE, HER OXYGEN LEVEL WAS SO LOW, AND OBSERVED. HER STOMACH WAS HUGE AND KEPT EXTENDING AND SHE BELIEVES THEY STARTED ANTIBIOTICS THAT DAY. A CT SCAN REVEALED HUGE POCKETS OF FLUID ALL OVER AND THEY WEREN'T SURE IF IT WAS BLOOD OR AN INFECTION OR FLUID. SHE HAD FLUID AROUND HER LUNGS CAUSING DIFFICULTY BREATHING. HER GYNECOLOGIST WAS PRESENT IN CASE SHE WAS NEEDED DURING THE SURGERY ON (B)(6) 2010 AND REPORTED THAT THE CONSUMER'S UTERUS AND TUBES WERE OKAY, THE CLEANEST SHE HAD SEEN FOR A CASE OF STREPTOCOCCUS. FOLLOWING SURGERY, THE CONSUMER WAS PUT ON THE VENTILATOR FOR TWO DAYS. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 AND WAS SEEN EVERY OTHER WEEK FOR BLOOD TESTS; EVERYTHING HAS BEEN CLEAR AND SHE WILL NOW ONLY SEE THE DOCTOR IF ANYTHING CHANGES. SHE IS TAKING IRON UNTIL 'EVERYTHING IS BACK UP TO WHERE IT WAS' AND STILL HAS PAIN FROM THE INCISION. THE CONSUMER MENTIONED THAT SHE HAD FOUR C-SECTIONS THAT SHE BOUNCED RIGHT BACK FROM BUT THIS SURGERY SHE CAN'T JUST BOUNCE RIGHT BACK. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L