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

Model Number CK1-EU

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

Patient Problem Unspecified Infection (1930)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded following the treatment, and as a result, an evaluation of the device is not possible.However, the facility reported the device functioned as intended during use.The investigation is currently ongoing and a follow-up report will be submitted when additional information is available.

Event Description

On 06-apr-2018 a merz affiliate in (b)(6) became aware of a patient reported to have developed an infection post-cellfina treatment.The treatment date was reported as (b)(6) 2018 and the patient reported the infection on (b)(6) 2018.The patient had reportedly "played soccer [a few] days after the treatment." the physician prescribed antibiotics on (b)(6) 2018; however, no improvement was reported.On (b)(6) 2018 a local antibiotic gel was applied, followed by a rinsing of the infection on (b)(6) 2018.A smear of the infection site was taken on (b)(6) 2018.The infection was "scraped out" on (b)(6) 2018 and a reduction of the infection was reported.Subsequent to these actions, it was reported the patient has a "dimple after the scraping (loss of tissue volume).".

Manufacturer Narrative

An evaluation of the cellfina disposable kit used during treatment was not performed as the kit was discarded.The cellfina motor module was not suspected to cause or contribute to the adverse event as it does not make direct contact with the treatment area.A lot complaint history review was performed and showed there were no similar reports for this reported condition and complaint frequency is within acceptable levels.A lot history review showed one deviation related to this lot of cellfina disposable kits; however, this deviation would not have contributed to this event and this kit passed all required testing prior to release.A review of the patient complaint trend analysis for the reported condition of "infection" found that a trend for this condition has not been identified and will continue to be monitored.As the practice did not allege any malfunction of a device and evaluation of the available information did not find any evidence of malfunction, it is unknown if the ulthera device caused or contributed to the reported condition.The instructions for use for the cellfina system state: "light physical activity is allowed in the first 30 days, but extreme physical activity should be avoided during this time." as the patient was reported to have played soccer a few days following treatment, this has been attributed as the most likely root cause of the issue.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: THE CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 7477015
• MDR Text Key: 107023227
• Report Number: 3006560326-2018-00003
• Device Sequence Number: 1
• Product Code: OUP
• UDI-Device Identifier: 00840763100612
• UDI-Public: 00840763100612
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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 Expiration Date: 05/23/2018
• Device Model Number: CK1-EU
• Device Catalogue Number: CK1
• Device Lot Number: 46401248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR