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	Nerve Damage (1979); Pain (1994)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, and when additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
On (b)(6) 2019, a practice reported via email a patient who had received an ultherapy lower face and neck treatment on (b)(6) 2019 was experiencing, "left should[er] pain at night and left hand weakness/decreased strength" five days after the treatment.The practice then reported the patient was diagnosed with, "brachial neuritis caused by inflammatory response," was prescribed oral steroids and oral gabapentin, and is beginning physical therapy.
Additional Manufacturer Narrative
The actual devices used during treatment were not provided for investigation.However, the practice provided an ulthera system support log containing the patient's individual exam records.A review of the exam records within this support log revealed the ulthera equipment performed as intended and the devices were used in accordance with the ulthera system instructions for use.The review of this support log also identified two transducers were used along with the ulthera system control unit and handpiece during treatment.A review of the device history record (dhr) for the control unit used during treatment found no non-conformances or rework associated with the manufacture of this device.Two deviations were listed; however, these deviations were unrelated and would not have contributed to this reported event.A review of the handpiece and both transducer dhrs found no non-conformances, deviations, or rework was associated with the manufacture of these devices.All devices used during treatment passed required testing prior to distribution.A review of the ultherapy patient complaint trending analysis for reported issue of "tenderness/soreness/pain/sensitivity to touch" found that a trend has been identified and a capa has been opened to investigate the issue.A review of the ultherapy patient complaint trending analysis for reported issue "palsy or paresis - moderate" 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 stated the ulthera system devices performed as intended during treatment and no malfunctions were identified during investigation, it is not confirmed whether an ulthera device caused or contributed to the event and the root cause of the reported issues are unknown.However, a contributory role to the treatment with ulthera 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 or Problem Description
The physician assistant at the practice provided an update on the patient's condition on (b)(6) 2019, stating that the ".Patient is improving with regular physical therapy.A recent emg showed improvement of the patient's brachial neuritis.She is being seen regularly by her neurologist and physical therapist." 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: 8879089
• Report Number: 3006560326-2019-00017
• Device Sequence Number: 11294627
• Product Code: OHV
• UDI-Device Identifier: 00840763100155
• UDI-Public: 00840763100155
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VALIUM; VICODIN; VALIUM; VICODIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR