MAUDE Adverse Event Report: CHURCH AND DWIGHT CO, INC. REPLENS MOISTURIZER; LUBRICANT, PERSONAL

Lot Number UC7050LS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Blurred Vision (2137); Chills (2191); Urinary Frequency (2275); Patient Problem/Medical Problem (2688)

Event Date 12/25/2018

Event Type  No Answer Provided  

Event Description

Almost same exact thing as consumer i read about maude adverse event report (b)(6) 2014.The woman used replens 3 times in two weeks (so did i).She noticed her urine was cloudy for a couple of days, then experienced severe urine frequency overnight ( same for me.I also noticed bloating and a burning sensation in the abdomen that increased in severity with each additional use so stopped using.) the next morning, she had pain in lower left back that was not muscular.She suffered severe chills that night and back pain all day, as well as bathroom trips (also same except the chills).The next morning, knowing something was not right, she saw a doctor who diagnosed the problem as a kidney infection (for me, i woke up at 3 am, went to restroom and had terrible pain in the lower left back.Called to husband that something was wrong.Laid in bed until 4 am with increasing pain.Decided to wait and see if it got better with time as it was (b)(6) morning.The pain was unbearable with (which were frequent) trip to the restroom.Decided to go to the emergency room which is 40 min drive with husband driving.Hospital did a ct scan and found a stone.Diagnosed with kidney stone.The hospital did blood work that i don't know the results of yet and i had a cat scan which showed a kidney stone.I have an apt with a urologist five days from now.I plan to talk to her about how these symptoms began as soon as i started using the replens.I have no history of uti or kidney infections.Quantity: 1 applicator, frequency: every three days.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.For vaginal moisture.

• Brand Name: REPLENS MOISTURIZER
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH AND DWIGHT CO, INC.
• MDR Report Key: 8217521
• MDR Text Key: 132492572
• Report Number: MW5082845
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• 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: 01/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/22/2019
• Device Lot Number: UC7050LS
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 77