REPHRESH VAGINAL GEL

Description of Event or Problem

CONSUMER WAS IN THE EARLY WEEKS OF PREGNANCY WHEN SHE USED REPHRESH. SHE HAD A MISCARRIAGE AT 6 WEEKS. SHE HAD BEEN CRAMPING FROM THE START OF PREGNANCY. SHE STATED THAT AFTER USING THE REPHRESH GEL, ONLY MINUTES LATER, SHE HAD A STRANGE AND UNCOMFORTABLE FEELING IN HER STOMACH. SHE STATED FURTHER THAT SOMETHING TOLD HER SHE SHOULDN'T HAVE USED IT, JUST A FEELING SHE GOT. THE NEXT DAY, WHEN SOME OF THE GEL CAME OUT, SHE STARTED TO HAVE TRACES OF BLOOD. SHE HAD NOT HAD ANY PRIOR SPOTTING OR BLEEDING. SHE DOESN'T KNOW HOW MUCH REPHRESH PLAYED A ROLE IN WHAT HAPPENED IF AT ALL. SHE HAS SUFFERED RECURRING BACTERIAL VAGINOSIS FOR YRS.

Additional Manufacturer Narrative

THE CONSUMER DID NOT REPORT THE EVENT AT THE TIME OF THE OCCURRENCE. THE CONSUMER HAS USED THE PRODUCT SINCE THE EVENT WITHOUT ISSUE. THE CONSUMER WAS INFORMED THE MFR OF THE EVENT BECAUSE SHE IS PREGNANT AGAIN AND IS INTERESTED IN USING THE PRODUCT DURING PREGNANCY. THE CONSUMER WONDERED IN HINDSIGHT IF REPHRESH MIGHT HAVE BEEN RELATED TO THE MISCARRIAGE SINCE THE LABELING ADVISES TO CONSULT A DOCTOR BEFORE USE IF PREGNANT.