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

Model Number	CM1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested from the practice.The device is expected to be returned following communication with the practice on (b)(6) 2018.Following device evaluation activities, a supplemental medwatch form will be filed.
Event or Problem Description
On (b)(6) 2018, ulthera, inc., merz device innovation center became aware via email of a patient who was experiencing "keloid scarring" at "entry points" following a cellfina treatment performed on (b)(6) 2018.
Additional Manufacturer Narrative
An evaluation of the returned cellfina motor module was performed.A visual inspection found that the cellfina motor module did not show any sign of abuse, wear, tear, or tampering.A functional evaluation of the device was performed and found the motor module operated as intended with no issues found.An evaluation of the complaint history for this device found there has not been any other reported complaint record associated with this cm-1 motor module.An evaluation of the original device history record found that this motor module was subject to one deviation; however, this deviation was related to a box label and would not have contributed to the reported issue.A service history review was not performed as cellfina motor modules are not serviceable devices.The cellfina disposable kit associated with this event was discarded by the customer; therefore, an evaluation of this device was not performed.The lot number of this cellfina disposable kit was not provided by the facility.A review of the reported issue "scar (major) keloid" complaint trend analyses found that a trend for this condition has not been identified and will continue to be monitored.The investigation found no evidence the merz/ulthera devices involved with this event malfunctioned, and it is not confirmed whether a merz/ulthera device caused or contributed to the event.However, the reported condition was deemed potentially permanent so a decision to file was made.No additional information is available at this time.If additional information becomes available, as supplemental report will be submitted.

• Brand Name: THE CELLFINA SYSTEM
• Common Device Name: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 7944859
• Report Number: 3006560326-2018-00009
• Device Sequence Number: 856671
• Product Code: OUP
• UDI-Device Identifier: 00840763100384
• UDI-Public: 00840763100384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: CM1
• Device Catalogue Number: 5036029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 06/20/2019
• 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