MAUDE Adverse Event Report: VENUS CONCEPT LTD. VENUS VIVA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Scarring (2061); Skin Discoloration (2074)

Event Date 08/04/2017

Event Type  Injury  

Event Description

I purchased 3 venus viva treatments at (b)(6) for treatment of wrinkles, pore size and a scar on my face.After my last treatment, which they did on the highest setting, i had a long recovery (7 days instead of 1).My face never fully recovered and now my skin has permanent and uneven discoloration and dark spots.It also never improved any of the skin problems i originally purchased the treatments for.This has made me incredibly sad and self conscious.I often cry while putting on my makeup.I'm only (b)(6) and now my face makes me look 20 years older.Either the person who did my treatment did something wrong or the venus viva should be pulled immediately so others don't have to go through what i have.Pictures upon request.

• Brand Name: VENUS VIVA
• Type of Device: VENUS VIVA
• Manufacturer (Section D): VENUS CONCEPT LTD.
• MDR Report Key: 7334323
• MDR Text Key: 102345123
• Report Number: MW5075831
• Device Sequence Number: 1
• Product Code: GEX
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 68