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

Model Number CM-1

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

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

The device serial numbers, actual devices used during treatment, nor updates to patient status/resolution were provided by the practice despite attempts to gather/retrieve this information on 24-may-2019, 28-may-2019, 31-may-2019, and 06-jun-2019.Additional attempts to gather information regarding updates to the patient's resolution occurred on (b)(6) 2019 and (b)(6) 2019.As no malfunctions of a device were alleged and no device information was provided by the practice, no actual device evaluations, lot history reviews, device history reviews, or service history reviews could be performed.A review of the cellfina patient complaint trend analysis for the reported condition of "edema/swelling" revealed this condition has not occurred at a sufficient frequency to establish a trending limit.The patient investigation found not enough information was provided to confirm whether a merz/ulthera device malfunctioned or caused/contributed to the alleged patient issue.However, this event was deemed reportable as the patient alleged the condition has worsened after one year since treatment and due to available information permanent damage could not be excluded.No additional information is available at this time.Should additional information become available, a supplemental report will be filed.

Event Description

On 23-may-2019 ulthera received information that a patient treated with a cellfina system was involved in an adverse event.No other details were provided at that time.Ulthera initiated contact with the practice on 24-may-2019 to attempt to gather additional information.On 28-may-2019 the practice replied and alleged a patient was experiencing ".Increased swelling at several release sites on the buttocks.It has been one year since treatment.Since the treatment several areas have begun to become raised.They are not scars.They now appear to be swollen areas of tissue where releases were performed.This has gotten worse over time." according to additional information received, the patient was treated on the buttocks approximately one year ago (actual treatment date is unknown at this time).Twenty four narrow releases were performed during treatment at a depth of six millimeters and the equipment performed as intended without any known issues or malfunctions.The patient does not have a history of any other treatments in the area of treatment.The treatment provider reported attempting to inject one site with kenalog 5mg/ml to see if the area would flatten out and is waiting to see the results.The patient was scheduled for a follow-up appointment on (b)(6) 2019.On 20-jun-2019 the treatment provider responded to ulthera's request for information resulting from the patient's follow up appointment.The treatment provider stated "the injection helped some on the one spot.I injected another with a higher dose and will follow up with her in 4 weeks." no additional information is available at this time.

Manufacturer Narrative

The merz/ulthera device database was searched and identified this treating practice has two cellfina motor modules listed on their account.It cannot be confirmed which device was used for treatment during this event.As the physician did not allege any malfunctions and motor modules do not have direct contact with the patient, these devices were not requested back for evaluation.Cellfina motor modules cm101533 (listed in d4) and cm101538 were found to be registered to this practice.A device history review was performed on both devices, and revealed no non-conformances or reworks were associated with the manufacture of these motor modules.Both motor modules had one deviation noted during device manufacturing; however, this deviation is unrelated and would not have contributed to the event.Both motor modules passed all required testing prior to distribution.A service history review was not performed as cellfina motor modules are not serviceable devices.No additional information is available at this time.If additional information is received, a supplemental medwatch will be submitted.

• 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: 8724709
• MDR Text Key: 149072426
• Report Number: 3006560326-2019-00011
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• PMA/PMN Number: K150505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CM-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUMESCENT SOLUTION - USED FOR ANESTHESIA
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 48