BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLENS LONG-LASTING VAGINAL MOISTURIZER

    MDR report key: 4072739 · Received August 14, 2014

    Report

    Report Number
    3003491851-2014-00001
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    May 24, 2014
    Report Date
    August 14, 2014
    Manufacturer
    LIL DRUG STORE PRODUCTS, INC.
    Product Code
    NUC
    PMA / PMN Number
    K101241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON INFO ON THIS EVENT IS LIMITED TO THE INFO THAT THE CONSUMER PROVIDED ON THE (B)(4). WE HAVE REVIEWED ALL COMPLAINTS FOR REPLENS IN 2014, AND WE DO NOT HAVE ANY THAT APPEAR TO MATCH THIS EVENT. IF WE DID RECEIVE INFO FROM THIS CONSUMER, IT COULD NOT BE IDENTIFIED AS MATCHING THE MAUDE DATABASE INFO. WE DO NOT HAVE CONTACT INFO FOR THE CONSUMER OR THE DOCTOR, SO ARE UNABLE TO OBTAIN ADDITIONAL DETAILS. THE PRODUCT WAS NOT RETURNED AND A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. RELEASE SPECIFICATIONS FOR THIS LOT WERE CHECKED AND EVERYTHING MET PREDETERMINED RELEASE CRITERIA. WE HAVE NO REASON TO BELIEVE THAT REPLENS MALFUNCTIONED OR DEVIATED FROM SPECIFICATIONS. A REVIEW OF COMPLAINT DATA DID NOT REVEAL ANY RELEVANT TRENDS TO THE REPORTED LOT NUMBER. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. WE WOULD LIKE TO MAKE SOME GENERAL NOTES ON THIS EVENT. KIDNEY INFECTIONS (PYELONEPHRITIS) ARE A TYPE OF URINARY TRACT INFECTION (UTI) AND ARE USUALLY CAUSED BY MICROORGANISMS ASCENDING FROM THE BLADDER VIA THE URETERS INTO THE KIDNEYS. THERE ARE MANY RISK FACTORS FOR KIDNEYS INFECTIONS, AND WE DO NOT NOW THE PT'S RISK. LIKE OTHER UTIS, SYMPTOMS CAN PRESENT SUDDENLY. TO OUR KNOWLEDGE, REPLENS HAS NEVER BEEN DETERMINED TO BE RISK FACTOR IN ACQUIRING UTIS OF ANY KIND. (B)(4). NO PTS IN ANY CLINICAL STUDY EXPERIENCED A VERIFIED UTI, ALTHOUGH ONE COMPLAINED OF SYMPTOMS CONSISTENT WITH A UTI (INCREASED URINATION FREQUENCY). IF WE ASSUMED THIS WAS A UTI AND THAT IT WAS RELATED TO REPLENS USE, (B)(4). WE BELIEVE THAT THIS EVENT IS LIKELY TO BE AN UNFORTUNATE COINCIDENCE, NONETHELESS, OUT OF AN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS EVENT AS REPLENS MAY HAVE CAUSED OR CONTRIBUTED TO THE CONSUMER'S UTI.

    Description of Event or Problem · 1

    DURING A CHECK OF THE MAUDE DATABASE ON 07/17/2014, LIL' DRUG STORE PRODUCTS (LDSP) NOTED THAT AN MDR HAD BEEN FILED BY A CONSUMER, (B)(4). LDSP IS NOT AWARE OF THIS CONSUMER CONTACTING THE COMPANY AND DO NOT HAVE ANY ADDITIONAL DETAILS AVAILABLE. PER THE MAUDE DATABASE, THE WOMAN USED REPLENS 3 TIMES IN TWO WEEKS. SHE NOTICED HER URINE WAS CLOUDY FOR A COUPLE OF DAYS, THEN EXPERIENCED SEVERE URINE FREQUENCY OVERNIGHT. THE NEXT MORNING, SHE HAD PAIN IN THE LOWER LEFT BACK THAT WAS NOT MUSCULAR. SHE SUFFERED SEVERE CHILLS THAT NIGHT AND BACK PAIN ALL DAY, AS WELL AS BATHROOM TRIPS. THE NEXT MORNING, KNOWING SOMETHING WAS NOT RIGHT, SHE SAW A DOCTOR WHO DIAGNOSED THE PROBLEM AS A KIDNEY INFECTION AND IMMEDIATELY STARTED HER ON CIPROFLOXACIN, AND HER SYMPTOMS SUBSIDED BY MORNING. THE DOCTOR ATTRIBUTED HER CONDITION TO REPLENS "SINCE I DID NOTHING DIFFERENT THE PREVIOUS 2 WEEKS EXCEPT THE REPLENS". SHE DOES NOT MENTION ANY SPECIFIC TESTING, SO IT IS UNK IF ANY TESTING WAS DONE OR IF THIS RELATIONSHIP WAS BASED SOLELY ON THE HISTORY THE PT GAVE TO THE DOCTOR. WE WOULD LIKE TO ENCOURAGE THE CONSUMER TO CONTACT US SO THAT WE CAN OBTAIN FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486794 REPLENS LONG-LASTING VAGINAL MOISTURIZER LUBRICANT, PERSONAL NUC LIL DRUG STORE PRODUCTS, INC. 83008 RD17093A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention