TO DATE, PRODUCT DETAILS INCLUDING LOT NUMBER WAS NOT PROVIDED BY REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PROCTER & GAMBLE (P&G) IS SUBMITTING THIS REPORT ONLY BECAUSE IT BELIEVES AN EVENT THAT MEETS THE REQUIREMENTS OF 21 CFR PART 803 MAY HAVE OCCURRED. THIS DOES NOT MEAN THAT P&G BELIEVES THE DEVICE MANUFACTURED BY P&G MAY BE DEFECTIVE OR HAS MALFUNCTIONED, OR THAT A TAMPAX PRODUCT WAS IN FACT ASSOCIATED WITH AN ACTUAL CONSUMER INJURY. CONSEQUENTLY, THIS REPORT MUST NOT BE CONSTRUED AS AN ADMISSION OF ANY KIND BY P&G. REASON THAT THE DEVICE HAS NOT BEEN EVALUATED BY THE MFR: (B)(4).
D
Patient 1
TOXIC SHOCK [TOXIC SHOCK SYNDROME]. IN A COMA PROBABLY A COUPLE OF YEARS [COMA]. IT WENT THROUGH BONE MARROW [BONE MARROW DISORDER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE WITH AGE UNSPECIFIED, USED TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK, UNSPECIFIED TOTAL DAILY USE, AND WAS HOSPITALIZED FOR TWO MONTHS AFTER DEVELOPING TOXIC SHOCK. SHE REPORTED THAT ACCORDING TO THE DOCTORS, IT WENT THROUGH HER BONE MARROW AND SHE HAD TO HAVE ARTIFICIAL HIP AND SHOULDER SURGERY TO TREAT THE SYMPTOM; SHE WAS ALSO IN A COMA. THE CONSUMER REPORTED THAT IT HAS BEEN A COUPLE OF YEARS AND SHE HAS VISITED SEVEN DOCTORS AND SURGEONS WHO ARE LOOKING AT HOW SHE BECAME SO SICK; THERE WAS NO CUT IN HER BODY SO THEY THINK THE TOXIC SHOCK WAS FROM THE USE OF TAMPONS. THE CASE OUTCOME WAS RECOVERED. OTHER PRODUCT USED PREVIOUSLY: YES - TAMPONS FOR 8-9 YEARS. NO FURTHER INFO WAS PROVIDED. ON (B)(6)-2008 RECEIVED CONSUMER'S FOLLOW-UP PHONE CALL: THE CONSUMER REPORTED THAT SHE WAS HAVING HER PERIOD AT THE TIME HER DOCTORS FOUND THAT SHE HAD NO CUTS ON HER BODY. NO FURTHER INFO WAS PROVIDED.