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

Model Number	UC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scarring (2061); Scar Excision (2358)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up inquiries to confirm device serial numbers and to obtain further information including patient treatment and medical records were sent on 19-sep-2017, 21-sep-2017, 22-sep-2017.If additional information should become available, a supplemental medwatch report will be submitted.
Event or Problem Description
On (b)(6) 2017, a merz field representative was made aware via a phone call from a treatment provider that a patient had a hypertrophic scar in the shape of one line on the lateral upper neck following an ulthera treatment.The full face ulthera treatment occurred on (b)(6) 2016.The serial number of the device was obtained from customer records.On (b)(6) 2017, the patient informed her ulthera provider that she had a hypertrophic scar.The doctor recommended a silicone stretch sheet band-aid at that time.On (b)(6) 2017, the patient had a follow up appointment during which the provider determined that the scar was worsening and extending, turning into a keloid scar.The provider excised the hypertrophic scar on that day.
Additional Manufacturer Narrative
An evaluation of the returned product was not performed.No evaluation of this product was conducted, because the device was not returned under this complaint rma.Additionally, no information regarding the ultherapy device such as a support log was provided by the health care provider, despite multiple follow-ups on 09/19/2017, 09/21/2017, and 09/22/2017.Based on these findings the reported issue was unable to be confirmed due to insufficient data.An evaluation of the device complaint history found that this control unit has never been returned for service and repair, although it has been captured under 2 complaint records for unrelated issues.An evaluation of the original dhr found that there has been no design changes associated with the ultherapy uc-1 control unit that could have contributed to the reported issue.There were no allegations of a problem with the device and the investigation did not confirm a malfunction of a merz/ulthera manufactured device.Since a device was not returned and no additional information was provided during this investigation or throughout follow-ups, it could not be confirmed whether or not the merz/ulthera device contributed to the alleged patient injury.A review of the "patient scar" complaint trend analysis was performed for the month of july 2018, and there was no trend.

• Brand Name: ULTHERA SYSTEM
• Common Device Name: ULTHERA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 6957084
• Report Number: 3006560326-2017-00015
• Device Sequence Number: 1111662
• Product Code: OHV
• UDI-Device Identifier: 00840763100216
• UDI-Public: 00840763100216
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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
• Device Catalogue Number: UC-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 08/20/2018
• 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
• Patient Age: 46 YR
• Patient Weight: 81