FDA Adverse Event Summary report: N

PROCTER & GAMBLE CO

MDR report key: 528257 · Received May 20, 2004

Report

Report Number
MW1032123
Date Received
May 20, 2004
Report Date
May 11, 2004
Manufacturer
PROCTER & GAMBLE CO
Product Code
HEB
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

RPTR IS IN RECEIPT OF LETTER DATED JANUARY 2004 WHEREIN MFR DISPUTES THEIR CLAIM THAT PEARL TAMPONS WERE RESPONSIBLE FOR AN INJURY SUSTAINED BY PT. MFR IS UNDER THE FALSE ASSUMPTION THAT PT FAILED TO INSERT THE TAMPON CORRECTLY AND COMPLETELY INTO THE VAGINA. PT DID INSERT THE TAMPON CORRECTLY AND COMPLETELY INTO THE VAGINA. IT WAS THE GETTING OUT PART THAT WENT WRONG AND BY NO FAULT OF THEIR DOING. RPTR HAS SEEN THE PEARL TAMPON COMMERICAL WITH THE COUPLE OUT ON THE BOAT AND THE WOMAN PULLS OUT A PEARL TAMPON TO CORRECT A LEAK IN THE BOTTOM OF THE BOAT. THE ADVERTISEMENT MAKES IT QUITE CLEAR THAT PEARL TAMPONS HAVE THE ABILITY TO STOP ANYMORE WATER FROM COMING INTO THE BOAT. IF IT HAS THAT KIND OF POWER THEN HOW DOES IT COMPROMISE A WOMAN'S VAGINAL FLUIDS AND CONSEQUENTLY, HER VAGINA, UTERUS, AND OVERALL HEALTH? THE PEARL TAMPON THAT PT USED OPENED UP LIKE A FAN, ABSORBED THEIR VAGINA COMPLETELY DRY AND WOULD NOT COME OUT WITHOUT EXTREME PAIN, DISCOMFORT, BLEEDING, WORRY, AND HOURS OF PATIENCE. THEY WERE SORE AND BLEEDING DAYS AFTER THEIR MENSTRUAL PERIOD ENDED. FAMILY IS NOT SATISFIED BY MFR'S DISMISSAL LETTER AND LACK OF SERIOUS CONCERN OVER THIS MATTER. RPTR FEELS P&G MUST TAKE FURTHER STEPS TO MAKE PEARL TAMPONS SAFER OR REMOVE THEM FROM MARKETPLACE SO THAT MORE WOMEN ARE NOT INJURED BY PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROCTER & GAMBLE CO PEARL TAMPONS HEB PROCTER & GAMBLE CO * *

Patients

Seq Age Sex Outcome Treatment
1 *