MAUDE Adverse Event Report: VELLA BIOSCIENCE VELLA WOMEN'S PLEASURE SERUM; LUBRICANT, PERSONAL

Patient Problem Local Reaction (2035)

Event Date 10/08/2023

Event Type  Injury  

Event Description

I purchased two satchets of the women's pleasure serum at flip shop.When i applied it onto my genital area, i experienced an adverse reaction.My husband also experienced an adverse reaction.Now, i am worried that i contracted a bacterial infection.According to the manufacturer, flip shop shipped an expired product which caused my adverse reaction.They refunded me (b)(6) which does not make things right.Their quality assurance oversight made me sick.Please hold flip shop accountable for sending me an expired product.I have enclosed the required lot numbers and manufacturing date in a screenshot.Ref report mw5146971.

• Brand Name: VELLA WOMEN'S PLEASURE SERUM
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): VELLA BIOSCIENCE
• MDR Report Key: 17941341
• MDR Text Key: 325752810
• Report Number: MW5146970
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White