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

Model Number	UC-1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Edema (1820); Full thickness (Third Degree) Burn (2696)
Date of Event	07/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ulthera, inc., merz device innovation center performed the investigation of the devices associated with this patient event.These devices include a control unit and handpiece that were received at the facility on (b)(6) 2015, as well as a transducer that was received at the facility on (b)(6) 2015.A support log review from the ulthera control unit found multiple instances of code j, as well as an instance of a missing log.Therapy tests/tcps were all functioning within normal ranges.Software issue could not be duplicated and all tests were passed.Acoustic power specification was found to be within specification.No image issues were found.If additional information should become available, a supplemental medwatch report will be submitted.This event was identified as being reportable as a result of a review of complaints received by ulthera, inc.Merz device innovation center.This submission is part of a correction documented in ulthera, inc., merz device innovation center capa-(b)(4).(b)(4).
Event or Problem Description
A merz affiliate located in (b)(6) notified ulthera inc., merz device innovation center on (b)(6) 2015 about a patient who allegedly experienced third-degree burns following an ultherapy treatment with transducer serial number (b)(4), handpiece serial number (b)(4), and control unit serial number (b)(4).The treatment was reportedly performed under anesthesia and resulted in scarring on the left cheek with swelling in the neck for approximately 10 days.

• 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: 6909760
• Report Number: 3006560326-2017-00013
• Device Sequence Number: 10792280
• Product Code: OHV
• UDI-Device Identifier: 00840763100179
• UDI-Public: 00840763100179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2015

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: 87017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2015
• Initial Report FDA Received Date: 10/03/2017
• 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: Other