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

Model Number	UC-1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Transducers involved in the treatment have not yet been returned and are currently awaiting shipment.When additional information regarding this event becomes available, a supplemental medwatch form will be filed.
Event or Problem Description
On (b)(6) 2018, a merz affiliate emailed to report that a patient experienced a burn on the abdomen following an ultherapy treatment.On (b)(6) 2018, the affiliate stated that the patient may need a skin graft to resolve the burn.The patient was provided with unknown antibiotics and antiphlogistics (believed to refer to anti-inflammatory medication).Subsequently, on (b)(6) 2018, the affiliate reported a diagnosis of a third degree burn and confirmed the patient had undergone a skin graft on an unknown date.
Additional Manufacturer Narrative
The transducers alleged to have been used during treatment on this patient were not returned by the practice to ulthera for investigation.The practice reported that the alleged devices continued to be used following this event, and there were no malfunctions or additional adverse effects reported to have occurred.The transducers were not available for evaluation as they had been used to completion and discarded.Multiple attempts to gather additional information were made on 28-jul-2018, 30-jul-2018, (b)(6) 2018, 15-aug-2018, 21-aug-2018, and 13-nov-2018; however, the practice refused to provide additional information regarding the event or status of the patient.A review of the device history record (dhr) for the control unit and related handpiece found that one unrelated deviation occurred during the manufacturing of the devices.A review of the dhrs for the alleged transducers used during treatment found no deviations or non-conformance occurred during the manufacture of these devices.All devices passed required testing prior to release.A service history review found that the control unit and handpiece have not been returned for service since distribution.A review of the ulthera complaint trend analysis for the reported patient condition of "patient burns" found that a trend had not been identified and will continue to be monitored.The patient investigation found that there are not enough details to confirm whether a merz / ulthera device caused or contributed to the event.The treatment was reported to have been performed on the abdomen which is an off-label area and may have contributed to the reported condition as no guidelines exist for treatments of this type.No additional information is available at this time.Should additional information become available, a supplemental medwatch will be filed.
Event or Problem Description
The patient's skin graft to treat the area on the abdomen that was involved with the burn occurred on (b)(6) 2018.Attempts to gather additional information regarding the patient, treatment / event details, and additional device information were not successful as the clinic refused to provide additional information.No devices are available for evaluation as the clinic continued to use the transducers after this treatment was performed without malfunctions or additional adverse effects on subsequent patients.No additional information is available at this time.

• 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: 7799815
• Report Number: 3006560326-2018-00008
• Device Sequence Number: 2076210
• Product Code: OHV
• UDI-Device Identifier: 00840763100247
• UDI-Public: 00840763100247
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 07/23/2019
• 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: Other; Disability
• Patient Age: 40 YR