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

Model Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event vascular occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse injectable implant could not be reviewed, as the lot number was not reported.
Event or Problem Description
This spontaneous report was received from a us healthcare professional and concerns a patient.The patient was injected with radiesse, into the jawline (off label use of device).During the radiesse injection, the patient experienced a vascular occlusion.The outcome of the event was unknown.
Additional Manufacturer Narrative
The device history record for radiesse injectable implant, lot number a00057880, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were reported related to this lot.
Event or Problem Description
Follow-up information was received on 17-jan-2023: the patients gender (female), age, date of birth and weight (approximately 63.5 kg) were provided.She was 50 years old at the time of the event.She was injected with one syringe of radiesse, on (b)(6) 2022.Batch number was reported as a00057880 (expiry date: 05/2025).A lot search in the global safety database was conducted.The batch record review was received and the lot number for radiesse was confirmed as a00057880 (expiry date: 05/2025).The patient had no prior fillers, no relevant medical history and no relevant concomitant medications.On (b)(6) 2022, 1 day after the treatment with radiesse, the patient experienced occlusion of the left jawline.Corrective treatment included 6.5 ml of hylenex, nitro paste to the area for 9 days, 3 ml of sodium thiosulfate, allegra tablets daily, baby aspirin daily, tylenol daily and 6 treatments with hyperbaric oxygen.By (b)(6) 2022, the issues were resolved (faint discoloration of the bruised area and the area was not tender to the touch, as reported).No laboratory tests were performed.The outcome of the event was reported as resolved (changed from unknown), in (b)(6) 2022.In the opinion of the reporter, the event was strictly caused by radiesse (considered as highly probable, changed from reasonable possibility).

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 15870654
• Report Number: 3013840437-2022-00154
• Device Sequence Number: 5210131
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3250502A000578806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 05/02/2025
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00057880
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/23/2023
• 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: CONCOMITANT DRUG NOT AVAILABLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 63 KG