MAUDE Adverse Event Report: REPLENS GEL VAGINAL MOISTURIZER; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Abnormal Vaginal Discharge (2123); Burning Sensation (2146)

Event Date 02/17/2017

Event Type  Injury  

Event Description

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.

• Brand Name: REPLENS GEL VAGINAL MOISTURIZER
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 6492992
• MDR Text Key: 72921035
• Report Number: MW5069077
• Device Sequence Number: 1
• Product Code: NUC
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 81