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	Nodule (4551)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received form a us health care professional and concerns a 62-year-old patient.The patient was injected with radiesse into the neck, for laxity (off label use of device), on (b)(6) 2024.In 2024, after the radiesse injection, the patient experienced nodules in the neck.On (b)(6) 2024 (ambiguously reported as (b)(6)), the patient had rechecks (as reported).The outcome of the event was unknown.Follow up information was received on 10-oct-2024: this case was upgraded to serious.Product preparation issue was added.The suspect product was recoded from radiesse to radiesse(+).Verbatim term was amended from nodules to nodules/lumps, coding remains unchanged.The patients gender (female) was provided.She was injected with radiesse(+), on (b)(6) 2024.Batch number was reported as a00121070 (expiry date: 13-aug-2025).The batch record review was received and the lot number for radiesse(+) was confirmed as a00121070 (expiry date: 13-aug-2025).A lot search in the global safety database was conducted.Radiesse(+) (1.5 ml) was mixed with 4.5 ml of normal saline (product preparation issue).The patient had 4 fraxel treatments in the areas treated with radiesse(+), most recently on (b)(6) 2024.She was previously injected with filler and tolerated it well each time.The patients medical history and concomitant medications were reported as none.On (b)(6) 2024, after the second radiesse(+) injection, the lumps were immediately palpable and the provider reported they massaged them aggressively and instructed the patient to do the same at home.No laboratory tests were performed.She had three visits, where the provider used a cannula to help break the nodules up by subsizing and injecting either lactated ringers or normal saline into the mass, along with massage in and out of office.Since then, the lumps got smaller.Treatment was necessary to accelerate recovery and the provider considered that the treatment was necessary to prevent permanent damage, as the nodules were too large to resolve on their own over time.The provider feared if they had left the nodules alone, they would become permanent.The patient had another check planned to determine whether resolution was reached.Due to the provided information, the outcome of the event was considered as resolving (changed from unknown).In the opinion of the reporter, there was a trouble inserting of cannula and the reporter assumed that they injected the product more superficially than desired.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event injection site nodule, was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for radiesse + lidocaine, lot number a00121070, 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.

• 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: 20578464
• Report Number: 3013840437-2024-00098
• Device Sequence Number: 8650258
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3250813A00121070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 08/13/2025
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00121070
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/31/2024
• Date Device Manufactured: 08/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female