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

Model Number CK-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

Multiple attempts to gather additional information including device serial/lot numbers and treatment/medical records have been made on 02-jul-2018, 13-jul-2018, 26-jul-2018, and 30-jul-2018 with no success.When additional information regarding this event becomes available, a supplemental medwatch form will be filed.

Event Description

On (b)(6) 2018, a merz employee forwarded a report from a practice via email stating that a patient was experienced scarring post cellfina treatment.The practice stated that the patient's cellfina treatment was performed on (b)(6) 2017 and she has subsequently developed scarring.The scarring persists despite three fraxel treatments and three limelight treatments to alleviate it.

Manufacturer Narrative

As the practice did not provide serial numbers of the devices used during this procedure, a review of sap found two serial numbers of control modules owned by the practice and two lots of disposable kits have been shipped to the practice.It is not confirmed which control module or disposable kit was used during this event despite attempts to obtain additional information on 02-jul-2018, 13-jul-2018, 26-jul-2018, 30-jul-2018 and 09-oct-2018.As the practice did not allege any malfunctions to have occurred with the devices and no malfunctions could be identified with the information provided, no cause could be confirmed.As the practice did not allege any malfunctions of a device, the devices were not requested for evaluation.An evaluation of the device history records for both control modules found that there have been no design changes associated with the control modules that could have contributed to the reported event, and both modules passed all required testing prior to distribution.An evaluation of the lot complaint history found that complaint levels for both disposable kit lots are within acceptable levels, and a lot history review of both kits showed all specifications and testing protocols were met prior to release.A review of the patient complaint trend analysis for the reported issue of "scar" found that a trend has not been identified and will continue to be monitored.Investigation of this report found that the merz/ulthera device did not malfunction as the practice stated the device performed as intended and no malfunctions could be identified from the information provided.Investigation was unable to confirm if the merz/ulthera device caused or contributed to this event.No additional information is available at this time.Should additional information become available, a supplemental medwatch will be filed.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 7741565
• MDR Text Key: 115764548
• Report Number: 3006560326-2018-00007
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• PMA/PMN Number: K161885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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
• Device Operator: Health Professional
• Device Model Number: CK-1
• Device Catalogue Number: 5036030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 06/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability