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 Problems Contusion (1787); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The treating provider stated on (b)(6) 2018 that the device performed as intended during the treatment.A follow up was made on (b)(6) 2018, with no response to date regarding the serial numbers of the devices used during the treatment and the patient's current resolution status.When additional information becomes available regarding this event, a supplemental medwatch form will be submitted.

Event Description

Merz device innovation center was made aware via email of a reported adverse event on (b)(6) 2018.A patient reported bruising, swelling, dents, ripples/bulges, and "red and obvious" incision sites post cellfina treatment.The treatment was reported to have occured on (b)(6) 2017.The treating practice stated that the patient was treated with hyaluronic acid filler in an attempt to mitigate or resolve the reported adverse events.

Manufacturer Narrative

The lot number of the disposable kit was not provided.No malfunctions of the device were alleged nor identified during the investigation.As the disposables kit was discarded and the motor module does not have direct contact with the patient, no devices were requested to be returned for evaluation.A review of the dhr found that this motor module was not subject to any rework prior to release.The patient alleged that areas of "fat herniation" would be treated with tempsure and sculpsure in (b)(6) 2018, but confirmation that procedures occurred was not provided.A review of the complaint trend report for "bruising", "edema", "skin surface convexity, depression or other irregularity", and "redness, erythema or rash" for the month of (b)(6) 2019 found that a trend has not been identified.The investigation found that there are not enough details to confirm whether a merz/ulthera device malfunctioned.It is unconfirmed whether a merz/ulthera device caused or contributed to the event.

• 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: 7469942
• MDR Text Key: 106792895
• Report Number: 3006560326-2018-00002
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CM-1
• Device Catalogue Number: CM-1
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 59