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 Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

No information regarding device serial/lot numbers or availability to be returned for investigation has been provided at this time.Additional attempts to gather additional information from the practice were performed on 16-jul-2019, 18-jul-2019, and 19-jul-2019.Additional attempts requesting the (b)(6) affiliate to follow up with the practice were made on 29-jul-2019, and 01-aug-2019.No additional information is available at this time.Once the investigation has been completed or if additional information is obtained, a supplemental medwatch will be filed.

Event Description

Merz/ulthera received a report from a (b)(6) affiliate on 10-jul-2019 regarding an allegation of a patient that developed lumps resembling lipomas following cellfina treatment seven months ago.The lumps have not been confirmed to be lipomas.According to the clinic that performed the procedure: "the nurse who performed the treatment reported that the lumps were not confirmed to be lipomas, she explained that she used the term 'lipoma' to best describe the appearance and density of the lumps based on her clinical assessment of the patient.No confirmatory testing/diagnostics have been performed to confirm whether the lumps are in fact lipomas.She explained that the treatment performed was along the p1 track.All of the lumps fall within the treatment track area, however there aren't lumps present in every site treated.The nurse reported that little red marks/bumps were still present at some of the blade puncture sites.The original treatment was performed on (b)(6) 2018.The patient reported to the clinic an 'irregularity' early on.The clinic instructed the patient to massage the area, ensure good nutrition, increase hydration and maintain exercise.The patient followed these instructions and reported that she gave her body 6 months to heal.She has seen efficacy of the treatment in removing her cellulite dimples; however, the lumps have caused her much distress.The patient came to the clinic on (b)(6) 2019 because she was very unhappy with the lumps.The nurse reported that the patient was emotionally very stressed as a result of these lumps.The patient reported that she had tried many things to reduce the lumps: lotions, cupping, professional massage, etc.But nothing helped.The patient is overall healthy, has no significant medical history and takes no medications regularly.The nurse considers this case to be of serious intensity based on the number of lumps present, their size and how they visibly protrude.The nurse cannot confirm a diagnosis and cannot confirm whether the lumps are permanent or not.The patient has not seen a physician as of yet." no additional information is available at this time.

Manufacturer Narrative

Additional information was received from the affiliate on 02-dec-2019 regarding this case.The patient reported additional details regarding the corrective treatments performed and the patient's initials were provided.No additional information is available at this time.If additional information is received, a supplemental medwatch form will be submitted.

Event Description

Received additional information from the canada affiliate on 02-dec-2019.The affiliate provided information obtained via the patient on (b)(6) 2019.The patient alleged, "i had cellfina a year ago done to my buttocks and upper back thighs.My results were terrible and now i'm left with very bad dimpling and bumps.I had 10 treatments of zeewave and 10 treatments of endymed done but nothing is helping smooth out areas where the bands that were cut by the cellfina procedure." no additional information is available at this time.

Manufacturer Narrative

The devices used during treatment were not provided for investigation.However, the practice's equipment records were searched to identify two cellfina motor modules sold to this practice.A review of the device history record (dhr) for both motor modules revealed no non-conformances or rework performed.The manufacture of both motor modules shared a matching deviation; however, this deviation is unrelated and would not have contributed to this reported event.Both devices passed all required testing prior to distribution.A review of the cellfina patient complaint trending analysis for reported issue "other" used to address the reported condition of "lipoma" revealed that the rate of occurrence is within allowable limits and will continue to be monitored.A review of the cellfina patient complaint trending analysis for reported issue of "scars" revealed that the reported issue has not occurred at a high enough frequency to generate a trend and will continue to be monitored.As the treatment provider did not allege a malfunction occurred with a cellfina device during treatment on this patient, it is not confirmed whether a cellfina device caused or contributed to the event and the root cause of the reported issues is unknown.However, a contributory role to the treatment with a cellfina system cannot be excluded with certainty.No additional information is available at this time.If additional information is received, a supplemental medwatch form will be submitted.

Event Description

Follow up information was provided by the practice.The nurse reported that the patient was seen by the clinic physician on (b)(6) 2019.The nurse could not confirm the physician's diagnosis or whether the physician assessed the condition as permanent or not.The nurse reported that no treatment has been provided to this patient.The physician recommended a treatment plan for the patient including a test patch treatment and laser skin tightening.The nurse could not confirm the name of the product or treatment recommended by the physician.The nurse confirmed that there has been no change to the patient's status or health.No additional information is available at this time.

• 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: 8855899
• MDR Text Key: 153153274
• Report Number: 3006560326-2019-00016
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 54