MAUDE Adverse Event Report: VIVEVE, INC. VIVEVE; ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES

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

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 12/19/2019

Event Type  Injury  

Event Description

Viveve burning sensation during treatment which was very painful.The entire time i was screaming whenever i felt this pain.The doctor adjusted the setting but it kept doing it over and over.I¿m not sure if it was malfunctioning and nothing was presented that showed machine was checked periodically for maintenance.Treat meant was cut short due to pain but i still paid 2k.I won¿t be doing this again.Fda safety report id # (b)(4).

• Brand Name: VIVEVE
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES
• Manufacturer (Section D): VIVEVE, INC.
• MDR Report Key: 9539154
• MDR Text Key: 173741689
• Report Number: MW5091971
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 61