REPLENS MOISTURIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-03 for REPLENS MOISTURIZER manufactured by Church And Dwight Co, Inc..

Event Text Entries

[132492572] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082845
MDR Report Key8217521
Date Received2019-01-03
Date of Report2019-01-01
Date of Event2018-12-25
Date Added to Maude2019-01-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREPLENS MOISTURIZER
Generic NameLUBRICANT, PERSONAL
Product CodeNUC
Date Received2019-01-03
Lot NumberUC7050LS
Device Expiration Date2019-02-22
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHURCH AND DWIGHT CO, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-03

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