MAUDE Adverse Event Report: REPLENS

Lot Number UF6029

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

Oby/gyn consult.Severe rash after using replens in conjunction with a personal exterior lubricant.Name of the company that makes (or compounds) the product: first response.Is the product over-the-counter: yes.Strength: 35 g grams.Quantity: 14 applicator.Frequency: twice a week.How was it taken or used: vaginal.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2016.Did the problem stop after the person reduced or stopped using the dose: yes.Did the person return if the person started taking or using the product again: yes.Why was the person using the product: vaginal dryness.

• Brand Name: REPLENS
• Type of Device: REPLENS
• MDR Report Key: 6025452
• MDR Text Key: 57557298
• Report Number: MW5065366
• 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: Other
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2016
• Device Lot Number: UF6029
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 56