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

Catalog Number	8071M0H1
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Deposits (1809); Subcutaneous Nodule (4548); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Case description: this spontaneous report was received from a us physician and concerns a 68-year-old male patient.The patient was injected bilaterally with radiesse from the lateral areas to the oral commissures (off label use of device), on 30-apr-2025.Batch number was reported as a00125150 (expiry date: 30-apr-2026).The batch record review was received and the lot number for radiesse was confirmed as a00125150 (expiry date: 30-apr-2026).A lot search in the global safety database was conducted.Four syringes of radiesse were injected using a needle.Radiesse was not diluted.The patient was previously injected with botox® and radiesse, which was well tolerated and without any adverse reactions.He had no past aesthetic injections in the area injected with radiesse.The patient was allergic to aspirin and penicillin.His relevant medical history included human immunodeficiency virus (reported as hiv +).His concomitant medications included biktarvy, serostim, losartan with amlodipine, testosterone, allopurinol, crestor, vesicare, and myrbetriq.On (b)(6) 2025, after the radiesse injection, the patient experienced that the area felt encapsulated, hard, like a lump lateral to the oral commissures bilaterally, that feels more of a product migration or accumulation in the area, and it looked like there was swelling.According to the physician, there was no clearly defined mass and it did not feel like a granuloma.The left side was bigger than the right side.It seemed as though the product was not absorbed by the skin.The patient was treated with hylenex.No laboratory tests were performed.The patient was not hospitalized and a diagnosis was not determined at the time of this report.The outcome of the events was reported as not resolved.In the opinion of the reporter, the events were not considered to be permanent, the treatment was necessary to prevent permanent damage and to accelerate recovery, and the events were related to the radiesse injection.Case amendment performed on (b)(6) 2025: case amendment was performed due to a technical issue related to information missing on the medwatch.
Additional Manufacturer Narrative
The batch record review for radiesse, lot a00125150, 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 a00125150) and no similar events were noted.This case was assessed by (b)(6) as serious.The events of product distribution issue, injection site induration, injection site swelling, and device dislocation were assessed as expected based on the currently valid us instructions for use leaflet of radiesse and possibly related to the treatment with radiesse.The reported left side was bigger is considered to be consequence of product distribution issue and therefore was not coded.Off label use of device was coded only for formal reasons.Injection from the lateral areas to the oral commissures is no approved indication for radiesse in us.Based on the information provided, this case was assessed as reportable to the fda as the events of product distribution issue and injection site induration were deemed to meet the serious injury criteria of required intervention to prevent permanent damage.Case amendment performed on (b)(6) 2025.Case amendment performed due to a technical issue related to missing information on the medwatch.Causality for the previously reported events remains unchanged as possibly related to the treatment with radiesse.Based on the information provided, this case was assessed as reportable to the fda as the events of product distribution issue and injection site induration were deemed to meet the serious injury criteria of required intervention to prevent permanent damage.

• 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: 22916362
• Report Number: 3013840437-2025-00113
• Device Sequence Number: 13227847
• Product Code: LMH
• UDI-Device Identifier: M2138071M0H15
• UDI-Public: +M2138071M0H15/$$3260430A00125150W
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: 04/30/2026
• Device Catalogue Number: 8071M0H1
• Device Lot Number: A00125150
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 05/01/2023
• 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: ALLOPURINOL (ALLOPURINOL); BIKTARVY (EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUM; CRESTOR (ROSUVASTATIN CALCIUM); LOSARTAN POTASSIUM AND AMLODIPINE (AMLODIPINE BESI; MYRBETRIQ (MIRABEGRON); SEROSTIM (SOMATROPIN); TESTOSTERONE (TESTOSTERONE); VESICARE (SOLIFENACIN SUCCINATE)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male