MAUDE Adverse Event Report: VIVEVE, INC. VIVEVE SYSTEM; ELECTROSURGICAL SYSTEM

Model Number	88003S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received a report from the patient via email on 20feb2020 alleging that she was burned during a treatment that occurred on (b)(6) 2020.Viveve contacted the treatment clinic and found that the actual treatment date was (b)(6) 2020.The treating physician had seen no burn and was treating the irritation with elta md silver gel.We have continued to reach out the clinic, the clinic has reached out to the patient, but no further information has been forthcoming.The only single use porting of the viveve system is the tip and it was not reused.The tip was not returned to viveve for investigation as the treating clinic no longer had the tip.Following fda's decision tree, this incident would have shown as non-reportable; however, viveve is reporting to provide additional information to the patient voluntary report to fda.
Event or Problem Description
Viveve does not believe this meets the criteria for a reportable event per the fda medical device reporting for manufacturers, guidance issued july 9, 2013.Viveve is reporting for completeness as we are aware the patient has voluntarily reported.Patient reported pain and an assumed burn.Followed up with the physician included irritation, no evidence of burn.

• Brand Name: VIVEVE SYSTEM
• Common Device Name: ELECTROSURGICAL SYSTEM
• Manufacturer (Section D): VIVEVE, INC.; 345 inverness drive south; building b, suite 250; englewood, co
• MDR Report Key: 9776962
• Report Number: 3013565579-2020-00002
• Device Sequence Number: 2185634
• Product Code: GEI
• UDI-Device Identifier: 00850794007132
• UDI-Public: 00850794007132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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
• Operator of Device: No Information
• Device Model Number: 88003S
• Device Catalogue Number: VIVGE01S
• Device Lot Number: 020140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other