REPLENS GEL VAGINAL MOISTURIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for REPLENS GEL VAGINAL MOISTURIZER manufactured by .

Event Text Entries

[72921035] Vaginal infection. I was prescribed replens vaginal moisturizer for vaginal dryness due to menopause. I started using product (b)(6) 2017. The first side effect was noticed after sexual intercourse, my husband's penis was covered with a white pasty discharge. My second side effect was a burning sensation in my vagina. My third side effect was itchiness in my vagina. I was prescribed to use once daily for 14 days. After the 14 days, i was prescribed twice weekly. Started my second tube on (b)(6) 2017. After sex, i noticed the discharge wasn't white, it was yellowish and more pasty (like there was little poppy seeds consistency in the mixture when rolled between thumb and forefinger). I got a little worried, so i decided to try douching on (b)(6) 2017. The douching flushed out quite a lot of this yellowish to brownish discharge. Some discharge seemed bloody tinged (which i would compare to the bloody discharge at the very end of a menstrual period). Thinking that i flushed it all out, but 3 days later, i douched with the same quantity of yellowish, brownish and blood tinged looking discharge flushed out again. I am really scared at this point. I stopped the replens treatment at once. Is the product over-the-counter: yes. Quantity: 1 2. 5 ml per unit. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069077
• MDR Report Key: 6492992
• Date Received: 2017-04-12
• Date of Report: 2017-03-19
• Date of Event: 2017-02-17
• Date Added to Maude: 2017-04-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: REPLENS GEL VAGINAL MOISTURIZER
• Generic Name: LUBRICANT, PERSONAL
• Product Code: NUC
• Date Received: 2017-04-12
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: REPLENS GEL VAGINAL MOISTURIZER
• Generic Name: LUBRICANT, PERSONAL
• Product Code: NUC
• Date Received: 2017-04-12
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-04-12