MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE + LIDOCAINE; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event vascular occlusion, was deemed to meet the serious injury criteria of required intervention to prevent permanent damage.The device history record for radiesse + lidocaine, lot number a00145480, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted related to this lot.
Event or Problem Description
This spontaneous report was received from an us physician and concerns a male patient.The patient was injected with a total of 1.5 ml of radiesse(+) into the left (as reported), on (b)(6) 2024 (reported as on friday).Batch number was reported as a00145480 (expiry date: 22-feb-2026).The batch record review was received and the lot number for radiesse(+) was confirmed as a00145480 (expiry date: 22-feb-2026).A lot search in the global safety database was conducted.In november 2024, after the radiesse(+) injection, the patient experienced a vascular occlusion.On (b)(6) 2024, in the morning, the patient called the physician and sent a picture.He was told to come to the physicians office where the physician saw the vascular occlusion.The outcome of the event was unknown.

• Brand Name: RADIESSE + LIDOCAINE
• 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: 20819473
• Report Number: 3013840437-2024-00107
• Device Sequence Number: 7683823
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3260222A001454801
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 02/22/2026
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00145480
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/02/2024
• 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
• Patient Sex: Male