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

Catalog Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event foreign body granuloma (injection site granuloma) 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 of radiesse injectable implant, lot number: a00066640, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.The lot was normal, no nonconformances was related to this lot.
Event or Problem Description
This spontaneous report was received from a us physician and concerns a patient.The patient was injected, with radiesse, into the jawline and cheeks (off label use of device).Months after the treatment with radiesse, the patient experienced delayed nodules under the skin.The outcome of the event was unknown.Follow-up information was received on 14-mar-2023: the case was upgraded to serious.The event term delayed nodules was changed to foreign body granuloma.The coding was changed from injection site nodule to injection site granuloma.The patients initials, age and date of birth were provided.The patient was 60 years old at the time of the event.The patient was injected with a total of 1.5 ml of radiesse, on (b)(6) 2022.Batch number was reported as a00066640.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 a00066640 (expiry date: 07/2025).The patient had no previous filler treatments.The patient had no relevant medical history or concomitant medication.In december 2022, after the treatment with radiesse, the patient experienced delayed nodules under the skin.On (b)(6) 2023, a biopsy was performed, and it showed foreign body granuloma.Corrective treatment included injection of 0.1 ml of hyaluronidase 150 mg/ml.In the opinion of the reporter, the treatment was not necessary to prevent permanent damage.On (b)(6) 2023, the patients condition improved.Due to the provided information, the outcome of the event foreign body granuloma was considered as resolving (changed from unknown).In the opinion of the reporter, the event was not permanent and 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: 16644706
• Report Number: 3013840437-2023-00033
• Device Sequence Number: 14825522
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K22
• UDI-Public: +M2138071M0K22/$$3250712A000666400
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: 07/12/2025
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00066640
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/30/2023
• 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: 60 YR
• Patient Sex: Unknown