MAUDE Adverse Event Report: ULTHERA, INC. MERZ DEVICE INNOVATION CENTER ULTHERA; ULTHERA AESTHETIC ULTRASOUND SYSTEM,

Model Number	UC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	04/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Practice reported to mdic on (b)(6) 2016 a female patient who had horizontal lines and divots on her chest area 6 months post décolletage treatment (b)(6) 2016.Medical intervention was recommended to the patient for full resolution thus considered a permanent injury.Per ulthera ifu, the possibility of scar formation may exist if incorrect treatment technique is used.Review of the support log shows no device malfunction.

• Brand Name: ULTHERA
• Common Device Name: ULTHERA AESTHETIC ULTRASOUND SYSTEM,
• Manufacturer (Section D): ULTHERA, INC. MERZ DEVICE INNOVATION CENTER; 1840 south stapley dr; suite 200; mesa AZ 85204
• MDR Report Key: 6149839
• Report Number: 3006560326-2016-00013
• Device Sequence Number: 509887
• Product Code: OHV
• UDI-Device Identifier: 00840763100186
• UDI-Public: 00840763100186
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/06/2016

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 Health Care Professional
• Device Model Number: UC-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• 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: Disability
• Patient Age: 45 YR
• Patient Weight: 84