MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. THE ULTHERA SYSTEM

Model Number	10290268
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Erythema (1840); Scar Tissue (2060); Wheal(s) (2241)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts to gather additional information regarding treatment details, devices used during this treatment, and the patient's recovery status are ongoing.The practice stated the ulthera equipment performed as intended during this treatment, and no malfunctions or any other device deficiencies occurred.On (b)(6) 2022, it was later reported by this same practice that transducer serial number (b)(4) suffered a membrane rupture causing the internal deionized water to leak out on (b)(6) 2022.It was later reported this transducer was also used during the treatment on (b)(6) 2022 related to this report, and the practice inquired if the membrane issue may have contributed to the adverse event.This device was received for evaluation, and the reported membrane rupture was confirmed.Due to the state of the transducer following the water leak, no additional functional testing could be performed.A review of this transducer's device history record found no deviations, rework, or non-conformances were associated with the manufacture of this device, and all tests conducted passed on the first attempt.As no membrane damage was reported during this patient's treatment, it is not believed this issue contributed to the reported adverse event.When a transducer's membrane fails in this manner, it is considered a catastrophic failure and renders the device unusable.A review of the current version of the ulthera patient complaint trend analysis for the conditions of welt and patient burn revealed the trends are within allowable limits and will continue to be monitored.The conditions of erythema and bruise have not reportedly occurred at a high enough frequency to generate a trend and will continue to be monitored.It is unconfirmed whether a merz/ulthera device caused or contributed to the event.An assessment of this patient's condition determined the linear lines/scars are potentially permanent; therefore, this case was deemed reportable.A contributory role of the ulthera system could not be excluded with certainty.No additional information is available at this time.If additional information becomes available, a supplemental medwatch form will be submitted.
Event or Problem Description
A merz (b)(4) affiliate reported via email on (b)(6) 2022 regarding an alleged adverse event following an ultherapy treatment.According to the report, "39-year-old patient with no medical or surgical history of interest.She comes to the consultation for ultherapy treatment of the lower third, she is aware of the process, which has already been carried out on another occasion in another country.On (b)(6) 2022 ultherapy treatment was performed on the lower 2/3 of the face and neck, 400 total lines combining transducer 4-4.5 at 1.20j and 7-3.0 at 0.30j.Well tolerated treatment with no incidents during it.At the end of the treatment, the patient presented moderate erythema and discrete edematous lines on both cheeks, home diprogenta and sun protection were prescribed.On february 28th, the patient sends photos showing inflammation, hematoma and linear lesions mainly on both cheeks.Due to personal problems, the patient did not go to control until (b)(6) 2022, an inflammatory process is observed above the usual, erythema on both cheeks, hematoma and linear lesions with loss of continuity of the skin.Since then, periodic check-ups have been carried out on the patient and different anti-inflammatory and regenerative treatments have been carried out in order to restore her skin.Currently, the patient presents linear scar remains, with small dots on both cheeks." it was reported the patient returned to the practice twice (unknown date and (b)(6) 2022) for proactive treatment of the reported issues.The patient was treated with a 595nm pulsed dye laser at low fluence to reduce erythema and red led treatment as an anti-inflammatory.It was reported two sessions were repeated; however, it is unknown which date(s) these sessions were allegedly performed.This patient was also provided matricium and cicaplast topical treatment and two platelet-rich plasma sessions on the affected area to regenerate tissue.Peeling with tranexamic acid to prevent post-inflammatory hyperpigmentation, a regenera® session to promote regeneration of damaged tissue, and a fractionated icon laser session to smooth the skin were also performed.A report for a damaged membrane resulting in the internal water leaking out of a transducer (serial number (b)(4)) was received on (b)(6) 2022.This issue reportedly occurred on (b)(6) 2022.The affiliate stated this transducer was used during the treatment on (b)(6) 2022 and inquired if this issue could have been related to the reported adverse event.As this transducer was reportedly used during the treatment related to this adverse event, this investigation will be included on this report.

• Brand Name: THE ULTHERA SYSTEM
• Common Device Name: THE ULTHERA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer Contact: robert wdowicki ; 13900 w. grandview parkway; sturtevant, WI 53177 ; 2628353396
• MDR Report Key: 14738772
• Report Number: 3006560326-2022-00003
• Device Sequence Number: 2030200
• Product Code: OHV
• UDI-Device Identifier: 00840763100865
• UDI-Public: 00840763100865
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K180623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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 Expiration Date: 09/21/2022
• Device Model Number: 10290268
• Device Catalogue Number: UT-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 39 YR
• Patient Sex: Female