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

Catalog Number	8063M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular occlusion (vascular occlusion), was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.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 health care professional and concerns a patient.The patients initials, gender and date of birth were reported as unknown.The patient was injected with radiesse(+), into the jawline (off label use of device).Batch number was unknown.After the treatment with radiesse(+), the patient experienced a vascular occlusion.The patient felt discomfort, their lip turned white and the bottom lip was swollen.The outcome of the event was unknown.
Additional Manufacturer Narrative
The device history record of radiesse (+) injectable implant, lot number a00041280, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformance was related to this lot.
Event or Problem Description
Follow-up information was received on 28-mar-2023: the patient was injected, with approximately 0.2 ml of radiesse(+), on 22-feb-2023.Batch number was reported as a00041280 (expiry date: 12/2023).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 a00041280 (expiry date: 12/2023).The patients medical history and concomitant medications were reported as none.On (b)(6) 2023, after the treatment with radiesse(+), the patient experienced a vascular occlusion.Corrective treatment included aspirin, hylenex, sodium chloride, prednisone 20 mg (for 3 days) and warm compresses / massage.No relevant laboratory tests were performed.The outcome of the event was reported as resolved, on the same day, on (b)(6) 2022 (changed from unknown).The outcome was reported as excellent, with no residual symptoms.In the opinion of the reporter, the event was related to radiesse(+).

• 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: 16503805
• Report Number: 3013840437-2023-00023
• Device Sequence Number: 14278173
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K22
• UDI-Public: +M2138063M0K22/$$3231215A00041280Y
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/04/2023

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: 12/15/2023
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00041280
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/04/2023
• 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; CONCOMITANT DRUG NOT AVAILABLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown