MAUDE Adverse Event Report: ULTHERA, INC. ULTHERA; ULTHERA CONTROL UNIT

Model Number	UC1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system support log was reviewed with no warnings or error codes on the date of treatment.Support log review.
Event or Problem Description
The health care provider reported 9/8/2016 that a patient had welts as a result of her (b)(6) 2016 chest treatment.As of 3/15/2017 the patient welts remain in the form of a scar.

• Brand Name: ULTHERA
• Common Device Name: ULTHERA CONTROL UNIT
• Manufacturer (Section D): ULTHERA, INC.; 1840 s stapley dr # 200; mesa AZ 85204
• MDR Report Key: 6429757
• Report Number: 3006560326-2017-00005
• Device Sequence Number: 551159
• Product Code: OHV
• UDI-Device Identifier: 00840763100223
• UDI-Public: 00840763100223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2017

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: Other
• Device Model Number: UC1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 03/23/2017
• 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: Required Intervention; Disability