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

Model Number	UC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received thus far, no reported issues or malfunctions of a device were alleged.Attempts to gather additional information regarding the patient, treatment, event, and device details occurred on (b)(6) 2019 and (b)(6) 2019.No additional information is available at this time.When additional information is received and/or when the investigation has been completed, a supplemental report will be submitted.
Event or Problem Description
A (b)(6) affiliate reported via email on (b)(6) 2019 that a doctor alleged a patient citing fat/volume loss on her face following two ultherapy treatments.The doctor reported that the patient's first treatment occurred in "(b)(6) 2017" and was re-treated "six months later." the doctor continued that "very significant unilateral volume loss identified by end of 2018, a year from second treatment.Clinical presentation of ae delayed possibly due to the patient receiving juvederm filler after ultherapy then indentation appeared afterwards after filler started to wear off - onset of ae was approximately 15 months following original lines.Fillers used to treat ae with improvement but not as easy to lift the face due to possible fibrosis in the area ultherapy was given.Patient saw a surgeon who said the patient requires a fat graft and full face lift.Attempts to gather additional patient/device/treatment information relating to the event occurred on (b)(6) 2019 and (b)(6) 2019.No additional information is available at this time.
Event or Problem Description
The united kingdom merz affiliate reported additional information regarding this adverse event.The following is a timeline of events: a 51-year-old female patient was treated with an ulthera system in (b)(6) 2017 using 400 lines, and also reported an initial "homeopathic" treatment of around 500 lines on the lower face (date of this treatment is unknown).The patient reportedly had previously undergone filler treatment prior to ultherapy.She experienced a slight stinging sensation and some swelling following the first ulthera treatment.Following this first treatment, she felt there had been no improvement with the ultherapy.She returned to the clinic six months later where she underwent a second treatment of ultherapy.Following this second treatment, she stated that she could see a transverse line on her left cheek.She was offered a treatment with pelleve and received this in (b)(6) 2018.She found this was a training session during which both the trainer and a trainee used pelleve on her cheeks.Following this, she noticed progressive deterioration, particularly of her left cheek.In (b)(6) 2018, the patient underwent further filler injections to her cheeks (approximately 4 ml).She underwent further filler treatments and felt that her right cheek was more prominent than her left.She was referred to another surgeon who reviewed her photographs, but was not formally examined by him.She then saw a new surgeon to consider fat grafting.The surgeon examined her and suggested that she receive a full face lift and fat grafting to the left cheek area.The examination was performed on (b)(6) 2019.The patient's main concern was her facial asymmetry, and also stated that the left cheek has a depression and the right cheek was prominent.The examination of the left side of her face showed an inverted triangular depression around the left malar region.This appeared to correspond to the superficial medial fat pad which appeared to have lost its volume.The nasolabial fat pad was present on the lateral cheek fat pad.The underlying deep fat compartments appeared to be intact and not disrupted.The right malar cheek region appeared over filled with the presence of previous filler.The right superficial medial fat pad appeared to be over filled and was slightly prominent.There appeared to be areas of fillers around the temple on both sides.On her lower face, the jawline appeared to have grade 1/2 laxity with no fat asymmetry.The lower jawline did not appear to have improved from the initial treatment programs.In the opinion of the surgeon before considering formal treatment, it was determined to be sensible to review the specific areas of fat loss/asymmetry and where the fillers were present.This was ascertained with a mri scan which would allow the fat and fillers to be delineated as well as any volumetric assessments to be made.Following this, it was determined prudent to consider enzymatically removing the hyaluronic acid fillers completely with hyaluronidase and then review the situation with regards to her facial asymmetry.The patient was of the opinion that the right cheek was also too prominent, and therefore before balancing the left cheek, it was deemed important to ensure the surgeon knew what her final expectations would be.Once the fillers were removed, the facial areas were assessed and decisions could be made regarding volumetric changes if required.There was no major skin laxity in the upper facial region and she would only require fat grafting as she was not keen to have further temporary fillers in this area.The patient was informed the lower face could be addressed with one of several techniques.On (b)(6) 2019, the physician reported that the patient had a surgical face lift and fat grafts and during this treatment the surgeon had advised her that she had experienced a deep sub dermal burn (4cm x 2cm).No additional information is available at this time.
Additional Manufacturer Narrative
The actual devices used during treatment were not provided for evaluation.Additionally, no information regarding serial numbers of devices used during either of the two reported ultherapy treatments on this patient were provided.No allegations of an ulthera device malfunctioning during either of the patient's ultherapy treatments were reported.As no serial numbers of devices used during the patient's treatments were provided, a formal investigation involving review of device history records and/or service history could not be performed.A review of the ultherapy patient complaint trend analysis for the reported issues of fat/volume loss, dissatisfaction, and burn showed that no adverse trends have been identified and will continue to be monitored.No additional information is available at this time.Should additional information be obtained, a supplemental medwatch will be submitted.

• Brand Name: ULTHERA SYSTEM
• Common Device Name: ULTHERA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 8785081
• Report Number: 3006560326-2019-00013
• Device Sequence Number: 12762262
• Product Code: OHV
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: UC-1
• Device Catalogue Number: UC-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR