MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE(+) INJECTABLE IMPLANT; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event lump/nodule (pt: injection site nodule), was deemed to meet the serious criteria of permanent damage, as permanent damage cannot be excluded with certainty.The device history record for radiesse(+) injectable implant, lot number a00049950 was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.Nonconformances were noted related to this lot, but none that would have contributed to this event.
Event or Problem Description
This spontaneous report was received from a us health care professional and concerns a female patient.She was injected with radiesse, in (b)(6) 2023.After the radiesse injection, the patient experienced a lump forming.She thought it would go away on its own, however, it did not.On (b)(6) 2024, the health care professional saw the patient.The outcome of the event was unknown.Follow-up information was received on 23-feb-2024: the case was upgraded to serious.The suspect product was recoded from radiesse to radiesse(+).The event verbatim was amended from lump to lump/nodule and the coding remained unchanged.The patients initials, age, date of birth (1952) and weight (54.4 kg) were reported.She was 71 years old at the time of the event (ambiguously reported as 72 years old).She was injected with 1.5 ml of radiesse(+), into the cheeks (off label use of device), in 2023.Batch number was reported as a00049950.The batch record review was received and the lot number for radiesse(+) was confirmed as a00049950 (exp.02/2024).A lot search in the global safety database was conducted.She was injected with about 0.75 ml per side.The patient was previously injected with belotero, radiesse and other hyaluronic acid fillers.The patients medical history and concomitant medication was reported as none.In (b)(6) 2023, after the radiesse(+) injection, the patient experienced a non-mobile, dime sized nodule in the right cheek, possibly in the subcutaneous place.The patient reported noticing the lesion almost immediately after her treatment but did not mention anything because she thought it would resolve on its own.In (b)(6) 2024, she reported it and said that it did not change since she noticed it.In (b)(6) 2024, corrective treatment included flushing by another provider, in the area with saline but it did not resolve the issue.The outcome of the event was reported as not resolved (changed from unknown).In the opinion of the reporter, the event was permanent and related to radiesse(+) since it was the only injectable used in the area and there was no prior nodule before injecting it.

• 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: 18831641
• Report Number: 3013840437-2024-00021
• Device Sequence Number: 11532101
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3240223A000499505
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 02/23/2024
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00049950
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/04/2024
• Date Device Manufactured: 02/23/2022
• 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: Disability
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG