MAUDE Adverse Event Report: LIL DRUG STORE PRODUCTS 8775076516 REPLENS VAGINAL MOISTURIZER 6.79; LUBRICANT

Lot Number RD17093A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994); Chills (2191); Urinary Frequency (2275)

Event Date 05/24/2014

Event Type  Injury  

Event Description

As a healthy (b)(6) year old woman, i used replens only 3x in 2 wks.I started noticing my urine was cloudy for a couple of days, then experience severe urine frequency overnight.Next morning i had a pain in my back on the lower left side, and it was not muscular.Severe chills that night and back pain was all day, as were bathroom trips.The next morning my condition didn't change and i knew something was not right.This was saturday (b)(6).I saw dr (b)(6) in the hamptons who was so alarmed about my kidney infection that he said i needed an iv now to get the medication asap.He said had i waited till (b)(6) it would've been in my bloodstream and i'd be in the hospital.After taking cipro that night, my symptoms subsided by morning.Dr (b)(6) attributed my condition to replens since i did nothing different the previous 2 wks except the replens.Pls note: the fda approved replens after a study of only 50 women enrolled, and only 38 completed it after 12 wks.Really???! after reading consumer reviews, many women have contracted uti's, bleeding, and kidney problems.A kidney infection is serious enough along with the other symptoms and therefore the fda should not only be made aware of this but also look into this product with more depth and perhaps a larger and longer study.The ingredients are hazardous and being absorbed into the body, benzene, glycerine, etc.Unacceptable guys.Thank goodness i caught my infection before real harm was done.Can you say lawsuit? because if any woman gets seriously harmed she will bring a lawsuit.Please, i implore you to look into this product further before someone is seriously harmed! dose or amount: 1 pre-filled applicator.Frequency: every 3-4 days.Route: vaginal.Dates of use: (b)(6) 2014.Diagnosis or reason for use: "a long lasting vaginal moisturizer".

• Brand Name: REPLENS VAGINAL MOISTURIZER 6.79
• Type of Device: LUBRICANT
• Manufacturer (Section D): LIL DRUG STORE PRODUCTS 8775076516
• MDR Report Key: 3874070
• MDR Text Key: 4590907
• Report Number: MW5036569
• Device Sequence Number: 1
• Product Code: NUC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/01/2015
• Device Lot Number: RD17093A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 58