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

Catalog Number	8063M0K2
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Discoloration (2074); 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 health care professional and concerns a patient.The patient was injected with radiesse into the temple area (off label use of device).After the radiesse injection, the patient experienced swelling and bruising surrounding eye.The outcome of the event was unknown.Follow-up information was received on 14-aug-2025: this case was upgraded to serious.The suspect product was recoded from radiesse to radiesse (+).The events ridge/product migration and white were added.Event term was changed from bruising to bruising/black and blue, coding remains unchanged.The patient's initials, date of birth, gender, and weight (reported as approximately 54 kg) were provided.She was 58 years old at the time of the event.The patient was injected bilaterally with 1.5 ml of radiesse (+) into the temple area (off label use of device) on (b)(6) 2025.Batch number was reported as a00169980 (expiry date: 14-sep-2026).The batch record review was received and the lot number for radiesse (+) was confirmed as a00169980 (expiry date: 14-sep-2026).A lot search in the global safety database was conducted.The patient was previously injected with radiesse into the temples six times since 2019.She was also previously injected with juvederm ultra plus, once, with no previous complications.The patient's medical history included osteoporosis.She took medications for bone loss (as reported).On (b)(6) 2025, on her way home after the radiesse (+) injection, the patient experienced that her left eye was black and blue and her eye swelled.The patient reported that her lid obstructed her view.The patient called the provider on (b)(6) 2025 to report that her left eye was swollen, black and blue.The patient was treated with medrol dose pack for 5 days and keflex, to decrease the swelling and rule out (r/o) an occlusion.The patient recovered from black and blue (as reported) and vision has not been impaired since on (b)(6) 2025, but she now had a ridge on the eyelid that is white.As reported, it appears to be radiesse (+) caused by migration.Further corrective treatment included injection with normal saline twice, to flush the area on the patient's left eyelid, and once with vitrase.The last treatment was performed on (b)(6) 2025, the patient was concerned and wanted resolution.No laboratory tests were performed.The outcome of the event bruising/black and blue was reported as resolved in 2025.The outcome of the event ridge/product migration and white was considered not resolved.In the opinion of the reporter, the event was not considered to be permanent, treatment was necessary to accelerate recovery and to prevent permanent damage.The provider stated that since radiesse (+) was not so easily broken down and was unfortunately in her eyelid, it may take months or possibly years for removal.
Additional Manufacturer Narrative
This case was assessed by merz north america as non-serious.The event of injection site bruising was 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 swelling is considered to be a symptom of injection site bruising and therefore was not coded.Off label use of device was coded only for formal reasons.Injection into the temple area is no approved indication for radiesse in us.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 14-aug-2025: the batch record review for radiesse (+), lot: a00169980, 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: a00169980) and no similar events were noted.This case was upgraded to serious.The suspect product was recoded from radiesse to radiesse (+).The events ridge/product migration and white were added.Verbatim event term was changed from bruising to bruising/black and blue, coding remains unchanged.The outcome of the event bruising/black and blue was reported as resolved.This case was assessed by merz north america as serious.The events of device dislocation, injection site bruising, and injection site discolouration 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 swollen/swelling was considered to be a symptom of the reported event bruising/black and blue, and the reported lid obstruction/impaired vision was considered to be a consequence of the swelling, and therefore were not coded.Off label use of device was coded only for formal reasons.Injection into the temple area is no approved indication for radiesse (+) in us.Possible confounding factor in this case is the patients 6 previous injections with radiesse in the temple region since 2019.However, information provided was sparse and a contributory role of the treatment with radiesse (+) cannot be ruled out with certainty.Based on the information provided, this case was assessed as reportable to the fda as the event device dislocation was 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: 22874219
• Report Number: 3013840437-2025-00117
• Device Sequence Number: 12206354
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3260914A00169980K
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 09/14/2026
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00169980
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/22/2025
• 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: Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female