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

Model Number	UC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Partial thickness (Second Degree) Burn (2694); Pyogenic Infection (4554); Swelling/ Edema (4577)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment provider stated the ulthera equipment performed as intended, and no device malfunctions or error codes occurred during the treatment.An ulthera system support log retrieved from the control unit used for this treatment was provided by the practice.An evaluation of the support log confirmed that no error codes occurred during this treatment.The exam records within the support log pertaining to this patient's treatment were also reviewed.A review of the exam records revealed the number of lines administered during treatment were within the recommended guidelines per the ulthera system instructions for use (ifu).However, one transducer used during treatment was identified to be expired.Expired transducers are not recommended for use per the ulthera system ifu.The serial numbers of the ulthera system control unit, hand piece, and transducers used during the treatment were obtained from the support log exam records.A review of the service history for the ulthera control unit revealed this device has not been serviced since its initial distribution.A review of the service history for the ulthera hand piece revealed this device has been serviced twice since its initial distribution; however, there were no relevant findings that may have contributed to this reported adverse event.A review of the device history record (dhr) for the ulthera system control unit revealed no non-conformances or rework were associated with the manufacturing of this device.Three deviations were noted; however, they are not suspected to have caused or contributed to this reported adverse event.All required testing was passed prior to distribution.A review of the dhr for the ulthera system hand piece revealed no non-conformances or rework associated with the manufacturing of this device.Four deviations were noted; however, they are not suspected to have caused or contributed to this reported adverse event.All required testing was passed prior to distribution.A review of the dhr for transducer (serial number: (b)(4)) revealed no non-conformances, deviations, or rework were associated with the manufacturing of this device.One diagnostic test failed due to a communication error; however, this test was re-run with no rework required and passed on the second attempt.All other required tests were passed prior to distribution.A review of the dhr for transducer (serial number: (b)(4)) revealed no non-conformances, deviations, or rework were associated with the manufacturing of this device.All required tests were passed prior to distribution.A review of the current ultherapy patient complaint trending analysis for the reported issues of "burn," "erythema," and "edema" revealed all three trends are within allowable limits and will continue to be monitored.A review of the current ultherapy patient complaint trending analysis for the reported issue of "infection" revealed this reported issue has not occurred at a high enough frequency to generate a trend and will continue to be monitored.As the practice stated the devices performed as intended during treatment and review of the support log revealed no error codes occurred during treatment, it is confirmed that a merz/ulthera device did not malfunction during treatment.However, a contributory role of this ulthera system to the event cannot be excluded with certainty.No further information is available for this case at this time.If additional information is received, a supplemental medwatch form will be submitted.This case was previously submitted on time, in accordance with regulatory reporting guidelines for medical device reports, via mfr number 301380437-2021-00002.(b)(4).
Event or Problem Description
On 29-jun-2020, ulthera received information from a merz (b)(6) affiliate regarding an adverse event related to an ultherapy treatment performed on (b)(6) 2020.The affiliate reported, "we have received some complaints of patient injuries." no additional information was provided at the time.On 27-oct-2020, the affiliate reported additional information regarding this event.According to the report, "the patient has received an ultherapy full face and neck treatment using ds4-4.5 and ds7-3.0 on (b)(6) 2020.She had swelling and erythema on her neck immediately after the treatment, blisters appeared on the neck on (b)(6) 2020.The patient visited a dermatologist on (b)(6) 2020, she was diagnosed burnt on the neck skin due to the heat of ulthera treatment.Some secondary bacterial infection was presented in the area with yellow pus dots.The dermatologist has prescribed bactroban ointment and oral antibiotics to the patient.Upon follow up session with the same dermatologist on (b)(6) 2020, the patient had gradual improvement and with the blisters subsided, but red scar tissue appeared.The patient were prescribed silicone gel and 20% azelaic acid cream for scar and post-inflammatory pigmentation (pih) management.The last progress update was made on (b)(6) 2020, the patient's conditions is improving gradually, she will continue with the scar and pih treatment provided by the dermatologist and will the next follow up session be scheduled in 3 months." on 18-jan-2021, the affiliate reported additional information: "the patient visited the dermatologist (b)(6) 2021.Doctor commented that the burn on the left neck was fully recovered, the burn on right side of neck resulted in permanent scar with peripheral hyperpigmentation.Treatment for hyperpigmentation continues." the patient reports no history of other procedures performed in the treated area.No additional information is available at this time.

• Brand Name: ULTHERA SYSTEM
• Common Device Name: 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: 12925282
• Report Number: 3006560326-2021-00007
• Device Sequence Number: 4907115
• Product Code: OHV
• UDI-Device Identifier: 00840763100193
• UDI-Public: 840763100193
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female