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

Catalog Number	8063M0K1
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deposits (1809); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Case description: this consumer report was received from a us consumer and concerns an adult female patient.She was injected with radiesse (+) into her lips (off label use of device), on (b)(6) 2025.Batch number was reported as a00133450 (expiry date: 10/2025).The batch record review was received and the lot number for radiesse (+) was confirmed as a00133450 (expiry date: 10/2025).A lot searche in the global safety database was conducted.Radiesse (+) was injected instead of a hyaluronic acid (reported as ha) filler.The patient's medical history included asthma and autoimmune diseases.In 2025, after the radiesse (+) injection, the patient experienced enormous, painful calcium deposits/lumps in her lips.The plastic surgeon tried to cut the patients lips open and remove the filler, but was not able to do it without ruining the patients lips.The patients lips were blue throughout, with possible compromised circulation.A corrective treatment with thiosulfate was considered.A sample of the filler was sent to pathology, and radiesse(+) was confirmed.The patient wanted to get treatment options and was concerned about long term side effects of having radiesse(+) in her lips, especially with her compromised immune system.On a day of this report, a plastic surgeon injected the patient with a dissolving agent, dexamethasone.Due to the provided information, the outcome of the events was considered as not resolved.
Additional Manufacturer Narrative
The batch record review for radiesse(+), lot a00133450, contains nonconformance reports or corrective/preventive actions related to this lot, but none that would have contributed to this event.A lot search in the global safety database was conducted on the reported lot (batch a00133450) and similar events were noted.This case was assessed by merz north america as serious.The events of vascular compression and product distribution issue were assessed as expected based on the currently valid us instructions for use leaflet of radiesse(+) and possibly related to the treatment with radiesse(+).Off label use of device was coded only for formal reasons.Injection into the lips is no approved indication for radiesse(+) in us.This is a consumer case and medical confirmation is pending.Based on the information provided, this case was assessed as reportable to the fda as the events of vascular compression and product distribution issue 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: 21985329
• Report Number: 3013840437-2025-00060
• Device Sequence Number: 12899922
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K15
• UDI-Public: +M2138063M0K15/$$3251031A00133450Z
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 8063M0K1
• Device Lot Number: A00133450
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Female