BEUDAMED
    FDA Adverse Event Other Summary report: N

    REPHRESH VAGINAL GEL

    MDR report key: 2609673 · Received August 26, 2009

    Report

    Report Number
    3003491851-2009-00001
    Event Type
    Other
    Date Received
    August 26, 2009
    Report Date
    August 26, 2009
    Manufacturer
    LIL DRUG STORE PRODUCTS, INC.
    Product Code
    MMS
    PMA / PMN Number
    K021737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPHRESH VAGINAL GEL REPHRESH VAGINAL GEL MMS LIL DRUG STORE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other