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

Model Number	8063M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event severe nodularity (pt: injection site nodule), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse(+) injectable implant, lot number: a00083980, 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 a us physician and concerns a female patient.She was injected, with radiesse.On (b)(6) 2022, after the treatment with radiesse, the patient experienced severe nodularity along the nasolabial folds and marionette lines.After 4 months they elevated to perform intraoral excisions of the involved tissue.The patient was very upset as were they.Due to the provided information, the outcome of the event was considered as not resolved.Follow-up information was received on 24-mar-2023: the suspect product was recoded from radiesse to radiesse(+).The patients age, date of birth and weight (68.03 kg) were provided.She was 69 years old at the time of the events.She was injected, with a total of 3 ml radiesse(+), on (b)(6) 2022.Batch number was reported as a00083980.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 a00083980 (expiry date: 10/2024).She had no previous filler treatments.The patients medical history and concomitant medications were reported as none.The patient had a worsening of nodularity in the nasolabial folds and marionette lines, over 3 months.The nodularity was worsening and the patient was very upset.Corrective treatment included antibiotics and oral rinse.The patient did not feel steroid injections were going to be effective, therefore an intraoral surgical removal was performed.No relevant laboratory tests were performed.The nodularity decreased, but patient had swelling and left lower lip weakness due to the surgical intervention.They were hoping for complete resolution.Due to the provided information, the outcome of the event severe nodularity was considered as resolving (changed from not resolved).In the opinion of the reporter, the events were related to radiesse(+).Follow-up information was received on 03-apr-2023: the patient had previous filler treatments including radiesse.Corrective treatment included steroid injections which failed, followed by surgical removal, followed by antibiotics and oral rinse.The surgeon and the patient did not feel that the steroid injections were effective, therefore an intraoral surgical removal was performed.As reported, due to the provided information, the outcome of the event severe nodularity was considered as not resolved (changed from resolving).The patient was due for a follow up, on (b)(6) 2023.

• 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: 16683566
• Report Number: 3013840437-2023-00034
• Device Sequence Number: 17965194
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3241005A000839805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/05/2023

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: 10/05/2024
• Device Model Number: 8063M0K2
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00083980
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/05/2023
• Date Device Manufactured: 10/06/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG