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	01/23/2021
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 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 lot number 100132266 was reviewed.A lot search was conducted on the reported lot and no similar events were noted.No nonconformances were noted that would have contributed to this event.
Event or Problem Description
This spontaneous report was received from a us physician and concerns a female patient.She was injected with radiesse®.The batch record review was received and the lot number for radiesse® was confirmed as 100132266 (expiry date 07/2023).A lot search in the global safety database was conducted.After the treatment with radiesse®, the patient experienced a vascular exclusion on the left side of her face.It was urgent.The outcome of the event was unknown.Follow-up information was received on 10-feb-2021: the patients age was confirmed.She was (b)(6) years-old at the time of the event.The patient was injected with a total of 1.3 ml of radiesse®, into bilateral nasolabial folds (reported as nlf), on (b)(6) 2021.The patient had last radiesse® injected, on (b)(6) 2020.Concomitant medication was reported as none.On (b)(6) 2021, two days after the treatment with radiesse®, the patient experienced a vascular occlusion.As a corrective treatment, the patient received bacrim ds, topical antibiotic ointment and dressings.No relevant laboratory tests were performed.The outcome of the event was reported as pending.Due to the provided information the outcome of the event remained unchanged.As reported, permanent scaring was possible and treatment was necessary to prevent a permanent damage.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
• MDR Report Key: 11335244
• Report Number: 3013840437-2021-00017
• Device Sequence Number: 3416514
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3230730100132266X
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/16/2021

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: 07/30/2023
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: 100132266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR