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 Code	Scarring (2061)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the initial report, the treatment providers were contacted, however, they no longer work at the practice and do not have access to records in order to comment.The practice was contacted on (b)(6) 2017 and (b)(6) 2017 but to date has not provided any additional information or confirmed availability of the device or records associated to the device or treatment.When additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
On (b)(6) 2017, a patient contacted ulthera, inc., merz device innovation center and reported permanent scars, loose skin, and "concavities" following an ultherapy treatment on (b)(6) 2016.The patient also reported undergoing a prior ultherapy treatment on 2016-mar-17.The patient stated that she had fat grafting and a full face and neck lift to address the outcomes.
Additional Manufacturer Narrative
An evaluation of the support log was not performed because no support log was provided.No device malfunctions were alleged or discovered during investigation.Serial numbers of the transducers used during the treatments were not provided, so no devices were requested for return.The control unit was identified to be owned by the treatment provider; however it was unconfirmed to be used during this treatment.An evaluation of the original dhr found that this device passed all tests prior to release.A complaint review for this control unit found three prior product complaints and one prior patient complaint (for the first treatment of the same patient) for this control unit; however, this device has not been returned for service since the initial distribution.A physician from the treating office indicated from memory that there were no problems with the treatment outcome, but did not have access to medical records to reference as she was no longer associated to that office.A director currently associated with the office and with access to the medical records did not provide them despite multiple attempts.The plastic surgeon who performed the patient's facelift 14-months post ulthera treatment was contacted to request additional information, but they did not respond.Assessment(s) of the patient from other plastic surgeons referenced in allegations was not available, as contact information for those providers was not supplied.The attempts to gather additional information occurred on 16-nov-2017, 17-nov-2017, 21-nov-2017, and 26-apr-2018.A review of the complaint trending report for the month of february 2019 found no trend for "patient scar".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.Medwatch (b)(4) was filed by the patient and subsequently received merz on 05-sep-2018 (refer to e4).Should additional information become available, a supplemental medwatch will be filed.

• 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: 7102869
• Report Number: 3006560326-2017-00023
• Device Sequence Number: 13797690
• Product Code: OHV
• UDI-Device Identifier: 00840763100162
• UDI-Public: 00840763100162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K134032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2017

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2017
• Supplement Date Received by Manufacturer: 11/11/2017
• Initial Report FDA Received Date: 12/10/2017
• Supplement Report FDA Received Date: 03/08/2019
• 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
• Patient Age: 55 YR