MAUDE Adverse Event Report: REPLENS

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2016

Event Type  malfunction  

Event Description

Two weeks ago ((b)(6)) i used a product to perhaps help my mild vaginal dryness.I am (b)(6) years old.The product name was replens.Is the product over the counter: yes.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.

• Brand Name: REPLENS
• Type of Device: REPLENS
• MDR Report Key: 5959524
• MDR Text Key: 55215182
• Report Number: MW5064829
• Device Sequence Number: 1
• Product Code: NUC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM TABS 0.5MG; AMLODIPIUNE TABS 10MG; BIOTIN 5000 MCG; MULTIVITAMIN/MULTIMINERAL SUPPLEMENT; NASACORT ALIGN; OTC MEDS: D3 5000; TRIAMTERENE/HCT TABS 37.5/25
• Patient Age: 66 YR
• Patient Weight: 62