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

Medical Device Problem Codes	Off-Label Use (1494); 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	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Case description: this spontaneous report was received from a us physician and concerns a female patient.She was injected with radiesse (+) around the ear/hairline, to treat the temple (off label use of device) on (b)(6) 2025.Batch number and expiry date were reported as unknown.A 22 gauge cannula was used for the injection.Radiesse (+) was undiluted.In (b)(6) 2025, after the radiesse (+) injection, the patient experienced a suspected vascular occlusion.On (b)(6) 2025, the patient received an ultrasound visualization of the vasculature and received hyaluronidase (at least 14 vials), eliquis, prednisone, aspirin, viagra, and nitroglycerin tablets.On (b)(6) 2025 (ambiguously reported as today), the patient also started with hyperbaric oxygen therapy, twice daily.She was being closely monitored for at least the following few days.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 (+).Off label use of device was coded only for formal reasons.Injection around the ear/hairline to treat the temple is no approved indication 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.
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 (+).Off label use of device was coded only for formal reasons.Injection around the ear/hairline to treat the temple is no approved indication 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 16-jul-2025: vascular occlusion of the superficial temporal artery was confirmed via ultrasound.The event term suspected vascular occlusion was changed to vascular occlusion, coding remains unchanged.The outcome of the event was considered as not resolved.The reported swelling and discomfort are considered to be symptoms of vascular occlusion and therefore were not coded.The reported feeling unwell is considered to be consequence of vascular occlusion and therefore was not coded.Causality for the event 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.
Event or Problem Description
Case description: this spontaneous report was received from a us physician and concerns a female patient.She was injected with radiesse (+) around the ear/hairline, to treat the temple (off label use of device) on (b)(6) 2025.Batch number and expiry date were reported as unknown.A 22 gauge cannula was used for the injection.Radiesse (+) was undiluted.On (b)(6) 2025, after the radiesse (+) injection, the patient experienced a suspected vascular occlusion.On (b)(6) 2025, the patient received an ultrasound visualization of the vasculature and received hyaluronidase (at least 14 vials), eliquis, prednisone, aspirin, viagra, and nitroglycerin tablets.On (b)(6) 2025 (ambiguously reported as today), the patient also started with hyperbaric oxygen therapy, twice daily.She was being closely monitored for at least the following few days.The outcome of the event was unknown.Follow-up information was received on 16-jul-2025: vascular occlusion of the superficial temporal artery was confirmed via ultrasound.The event term suspected vascular occlusion was changed to vascular occlusion, coding remains unchanged.On (b)(6) 2025, the patient contacted the physician, reported that she was feeling unwell.The patient visited the emergency room (reported as er) and received corticosteroids, and she experienced temporary relief.On (b)(6) 2025 in the evening, the patient's symptoms worsened significantly, suggesting a potential vascular occlusion (vo) in the temple/head region.The reporting physician consulted with another physician who confirmed the vascular occlusion, and reviewed initial interventions with hyaluronidase, saline, baby aspirin, steroids, viagra, antibiotics, and valacyclovir.That physician also advised suspending any further injections and recommended reassessment the following day.On (b)(6) 2025, the patient was brought to a registered nurses clinic (reported as rn) for further management where a non-invasive radiofrequency treatment was applied to the affected area.A hotel room was arranged to ensure close monitoring, and the two physicians stayed with the patient overnight.Ultrasound on (b)(6) 2025 confirmed a vascular occlusion in the superficial temporal artery.The physician administered hyaluronidase again under ultrasound guidance.The patient began daily hyperbaric oxygen therapy.On (b)(6) 2025, the swelling and discomfort persisted, particularly around the ear, though skin tone appeared stable.The consulting physician recommended daily clinical monitoring and referred the patient to a local facial plastic surgeon for potential surgical or wound care intervention.Treatment plan included medications, twice-daily hyperbaric sessions, co2 lift carboxy therapy masks, and polydeoxyribonucleotide (reported as pdrn) application.The patients condition remained serious, with the long-term outcome still uncertain.The plastic surgeon was providing daily medical follow-ups, and during the consulting facial plastic surgeons absence, the patient was temporarily referred back to a consulting registered nurses (rn) clinic.Due to the provided information, the outcome of the event was considered as not resolved (changed from unknown).

• 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: 22470611
• Report Number: 3013840437-2025-00092
• Device Sequence Number: 4095359
• Product Code: LMH
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 07/21/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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 Sex: Female