MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received from a us health care professional and concerns a female patient.She was injected with 1 syringe of radiesse(+), into the neck (off label use of device), more than a month prior to the time of this report, in 2024.Radiesse(+) was diluted (product preparation issue), in a 1:3 dilution.In 2024, after the radiesse(+) injection, the patient experienced nodules in the neck.Corrective treatment included intervention with sterile water, microneedling and subcision multiple times, but the nodules were not resolved.The outcome of the event was reporte as not resolved.Follow up information was received on 16-may-2024: this case was upgraded to serious.The suspect product was recoded from radiesse(+) to radiesse.Product preparation issue was deleted as the patient was injected with diluted radiesse, not diluted radiesse(+).The patients initials, date of birth (1986), and age were provided.She was 36 years old at the time of the event (ambiguously reported as 37).The patient was injected with radiesse on (b)(6) 2022.Batch number was reported as a00060820 (expiry date: 06/2025).The batch record review was received and the lot number for radiesse was confirmed as a00060820 (expiry date: 06/2025).A lot search in the global safety database was conducted.The patients previous aesthetic treatments included a 3 pack of 1.5 inch firming threads in the neck (b)(6) 2021.The patients medical history and concomitant medication was reported as none.On (b)(6) 2022, the patient first reported the nodules on a follow up appointment.At this time, 2 units of hylenex were injected into the left neck nodules.On (b)(6) 2023, a neck ultrasound was performed and the interpreting provider did not find any nodules.Other corrective treatments included sterile water injections on (b)(6) 2023, (b)(6) 2023, (b)(6) 2023 and (b)(6) 2023.She also completed radio frequency (rf) microneedling treatments on (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2024 and (b)(6) 2024.The treatments were conducted to accelerate the recovery and resolve initial nodules.The patient stated there were still residual nodules and were not improved despite various treatments to resolve it.The outcome of the event remained unchanged.The reporter believed that the event was caused by radiesse.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event nodules (injection site nodule) were deemed to meet serious injury criteria of permanent damage.The device history record of radiesse injectable implant, lot number a00060820, was normal, no nonconformance reports or corrective/preventive actions related to this lot.The lot search was conducted on the reported lot and similar events were noted.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 19487377
• Report Number: 3013840437-2024-00056
• Device Sequence Number: 7164939
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3250607A000608200
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 06/07/2025
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00060820
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/07/2024
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT DRUG NOT AVAILABLE.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 36 YR
• Patient Sex: Female