MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC (FRANKSVILLE) RADIESSE(+); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	8063M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed by merz north america as non-serious.The event of injection site nodule was assessed as expected based on the currently valid us instructions for use leaflet of radiesse(+) and possibly related to the treatment with radiesse(+).Based on the information provided, there was no evidence of a reportable death, serious injury, or malfunction.Merz causality re-assessment due to follow-up information received on 02-oct-2025: the batch record review for radiesse(+), lot a00086920, was normal, no nonconformance reports, corrective/preventive actions related to this lot.A lot search in the global safety database was conducted on the reported lot (batch a00086920) and no similar events were noted.This case was upgraded to serious.The reported term bumps was changed to bumps/lumps/granulomatous reaction and the coding remained unchanged.The outcome of the event was considered as resolving.In the opinion of the reporter, the event was related to radiesse(+).This case was assessed by merz north america as serious.The event of injection site nodule was assessed as expected based on the currently valid us instructions for use leaflet of radiesse(+) and possibly related to the treatment with radiesse(+).Based on the information provided, this case was assessed as reportable to the fda as the event of injection site nodule was deemed to meet the serious injury criteria of required intervention to prevent permanent damage.
Event or Problem Description
Case description: this spontaneous report was received from a us physician and concerns a patient.The patient was injected with radiesse (+) into the hands, on (b)(6) 2024.One syringe of radiesse (+) was injected into each hand, using a 23 g cannula.In (b)(6) 2025, after the radiesse (+) injection, the patient experienced multiple bumps all over the hands, including one very large spongy lump on the left-hand measuring approximately 2.5 cm times 3.8 cm.In (b)(6) 2025, 1 ml of 5-fluorouracil, 0.5 ml of dexamethasone 4 mg, and 0.1 ml of kenalog 10 mg/ml were mixed in 1 syringe for the treatment of nodules.In (b)(6) 2025, no changes were observed in nodules.The patient was treated with colchicine 1.2 mg orally, as a single loading dose (reported as 1.2 mg/d po one day), followed by colchicine 0.6 mg orally twice daily for 5 days.In (b)(6) 2025, no changes in nodules were noted.Due to the provided information, the outcome of the event was considered as not resolved.Follow-up information was received on 02-oct-2025: this case was upgraded to serious.The reported term bumps was changed to bumps/lumps/granulomatous reaction and the coding remained unchanged.The patients initials, date of birth, gender and weight (66 kg) were provided.She was 58 years old at the time of the event.Batch number was reported as a00086920 (expiry date: 20-nov-2024).The batch record review was received and the lot number for radiesse(+) was confirmed as a00086920 (expiry date: 20-nov-2024).A lot search in the global safety database was conducted.Radiesse(+) was not diluted.Her concomitant medications included estradiol/progesterone, the patient had no known drug allergies (nkda).The patients past aesthetic injections included dysport, kysse, and lasers.The patient had no prior aesthetic injections in the areas injected with radiesse(+).At the time of this report, the large lump at the cannula insertion site on the left hand reduced by 75 percent since treatment with colchicine.About 15 other lumps had reduced by 40 percent.All lumps were still present.Due to the provided information, the outcome of the event was considered as resolving (ambiguously reported as not resolved), (changed from not resolved).In the opinion of the reporter, the event was related to the radiesse(+), treatment was necessary to prevent permanent damage, and the patient was not hospitalized.Therefore, the causality was changed from reasonable possibility/suspected to related.

• Brand Name: RADIESSE(+)
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC (FRANKSVILLE); 4133 courtney street, suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC (RALEIGH); 6501 six forks rd; raleigh NC 27615
• Manufacturer Contact: juan daccach ; 6501 six forks road; raleigh 27615 ; 919 582-8000
• MDR Report Key: 23299907
• Report Number: 3013840437-2025-00134
• Device Sequence Number: 11958835
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3241120A000869200
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2025

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: 11/20/2024
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00086920
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 11/21/2022
• 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: ESTRADIOL,PROGESTERONE (ESTRADIOL, PROGESTERONE)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 66 KG