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); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Case description: this spontaneous report was received from an us health care professional and concerns a female patient.The patient was injected with radiesse (+) into the temple (off label use of device), on (b)(6) 2025 (reported as tuesday prior to the date of this report).Batch number was reported as unknown.Radiesse (+) was hyperdiluted (reported as rhd) (product preparation issue, off label use of device) in a 2:1 ratio and injected using a 25g, 1.5 inch needle.In (b)(6) 2025, after the radiesse (+), the patient experienced a suspected occlusion in the temple.On thursday (b)(6) 2025, at 22:45 (reported as night at 1045), the patient stated she had some discoloration to her temple.It was spreading near the eye, down the cheek and up, near the forehead, with noted livedo reticularis.The patient did not have any pain or vision loss.Capillary refill was 2-3 seconds.Physician sent patient to another local injector to assess under ultrasound (reported as u/s) and plan treatment.The outcome of the event was unknown.
Additional Manufacturer Narrative
This case was assessed by merz north america as serious.The event of vascular occlusion 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 event discoloration to the temple and noted livedo reticularis are considered to be a symptom of vascular occlusion and were therefore not coded.Off label use of device and product preparation issue were coded only for formal reasons.Injection into the temple is no approved indication for radiesse (+) in us.Dilution of radiesse (+) for injection into the temple is not approved for radiesse (+) in us.Based on the information provided, this case was assessed as reportable to the fda as the event of vascular occlusion 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 an us health care professional and concerns a female patient.The patient was injected with radiesse (+) into the temple (off label use of device), on (b)(6)2025 (reported as tuesday prior to the date of this report).Batch number was reported as unknown.Radiesse (+) was hyperdiluted (reported as rhd) (product preparation issue, off label use of device) in a 2:1 ratio and injected using a 25g, 1.5 inch needle.In february 2025, after the radiesse (+), the patient experienced a suspected occlusion in the temple.On thursday (b)(6)2025, at 22:45 (reported as night at 1045), the patient stated she had some discoloration to her temple.It was spreading near the eye, down the cheek and up, near the forehead, with noted livedo reticularis.The patient did not have any pain or vision loss.Capillary refill was 2-3 seconds.Physician sent patient to another local injector to assess under ultrasound (reported as u/s) and plan treatment.The outcome of the event was unknown.Follow-up information was received on 04-aug-2025: the reported term suspected occlusion was changed to compression occlusion and the coding remained unchanged.Batch number was reported as a00170010 (expiry date: 23-sep-2026).The batch record review was received and the lot number for radiesse (+) was confirmed as a00170010 (expiry date: 23-sep-2026).A lot search in the global safety database was conducted.It was injected superficially.Radiesse (+) was diluted at a 3:1 ratio.The patient had prior aesthetic treatments and tolerated it well.The patient had no medical history or concomitant medications.On (b)(6)2025, after the radiesse (+) injection, the patient experienced the event.A diagnosis was confirmed as compression occlusion.It was dissolved by the physician who performed imaging of it.Laboratory tests were not performed.The outcome of the event remained unchanged.
Additional Manufacturer Narrative
This case was assessed by merz north america as serious.The event of vascular occlusion 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 event discoloration to the temple and noted livedo reticularis are considered to be a symptom of vascular occlusion and were therefore not coded.Off label use of device and product preparation issue were coded only for formal reasons.Injection into the temple is no approved indication for radiesse (+) in us.Dilution of radiesse (+) for injection into the temple is not approved for radiesse (+) in us.Based on the information provided, this case was assessed as reportable to the fda as the event of vascular occlusion was deemed to meet the serious injury criteria of required intervention to prevent permanent damage.Merz causality re-assessment due to follow-up information received on 04-aug-2025: the batch record review for radiesse (+), lot a00170010, was normal, no nonconformance reports, corrective/preventive actions related to this lot.A lot of searches in the global safety database was conducted on the reported lot (batch a00170010) and no similar events were noted.The reported term suspected occlusion was changed to compression occlusion and the coding remained unchanged.Causality 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 event of vascular occlusion 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: 21634201
• Report Number: 3013840437-2025-00039
• Device Sequence Number: 9276743
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3260923A00170010$
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 08/12/2025

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: 09/23/2026
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00170010
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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 Sex: Female