MAUDE Adverse Event Report: ULTHERA, INC ULTHERA; ULTHERAPY SYSTEM

Model Number	UC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not investigated.Multiple requests were made to obtain the system support log, but declined by the hcp.Support log review would identify if there were any anomalies during the treatment that would warrant further device investigation.
Event or Problem Description
On september 23, 2016 the health care provider reported that they conducted an off-label treatment to the back of the patients left arm on (b)(6) 2016 which resulted in the patient having difficulty gripping a piece of paper in her left hand, and numbness/tingling on that left arm and hand.She started taking the prednisone on monday (b)(6) 2016 and as of (b)(6) 2016 saw marked improvement.  the patient was able to grip with her left hand a piece of paper but still complained of weakness, tingling, and numbness.The health care provider updated to ulthera on december 9, 2016 that the patient is seeking treatment from a nerve specialist and reports limited mobility and sensation in her left hand.The patient wears a brace and is doing physical therapy. .

• Brand Name: ULTHERA
• Common Device Name: ULTHERAPY SYSTEM
• Manufacturer (Section D): ULTHERA, INC; 1840 s stapley dr; ste 200; mesa AZ 85204
• MDR Report Key: 6345474
• Report Number: 3006560326-2017-00001
• Device Sequence Number: 10933275
• Product Code: OHV
• UDI-Device Identifier: 00840763100476
• UDI-Public: 00840763100476
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: Health Professional
• Device Model Number: UC-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2016
• Initial Report FDA Received Date: 02/21/2017
• 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