MAUDE Adverse Event Report: VIVA CREAM FOR WOMEN SINGLE PACK; LUBRICANT, PERSONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 04/02/2022

Event Type  Injury  

Event Description

My finance and i went to (b)(6) on (b)(6) in (b)(6).We bought a product from them known as viva arousal cream for women.We tried the product before having sex.She claimed to have a burning sensation from it.It went away afterwards.The next day, she had a little bit of a burning sensation and her face was swollen from it.She is still having little bit of side effects from it.Please look into this as soon as possible.Thank you.

• Brand Name: VIVA CREAM FOR WOMEN SINGLE PACK
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 14075223
• MDR Text Key: 289093218
• Report Number: MW5108880
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: SERTRALINE; TRAZODONE
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White