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
Event or Problem Description
This mdr is related to mdr 3013840437-2023-00110 referring to the same patient.This spontaneous report was received from a us health care professional and concerns a patient.The patient was injected with radiesse, into the neck (off label use of device).Radiesse was hyperdiluted.After the radiesse injection, the patient experienced neck nodules.Corrective treatment included hylenex.The outcome of the event was unknown.Follow up information was received on 10-oct-2023: the case was upgraded to serious.The suspect product was recoded from radiesse to radiesse(+).The events product preparation issue and product distribution issue were added.The event term neck nodules was amended to nodules on the left medial neck and submental.Patients initials, age, date of birth, gender (female) and weight (about 74.8 kg) were provided.She was 56 years old (ambiguously reported as 57 years old) at the time of the event.She was injected with hyperdiluted (product preparation issue) radiesse(+), on (b)(6) 2023.Batch number was reported as a00066940 (expiry date: 07/2024).The batch record review was received and the lot number for radiesse(+) was confirmed as a00066940 (expiry date: 07/2024).The patient had follow up appointment on (b)(6) 2023 and on (b)(6) 2023, with reports everything was great, no nodules were present.She previously had neurotoxins, radio frequency (rf) microneedling, and a cool peel done on (b)(6) 2023.The patients medical history and concomitant medication was reported as none.In 2023, after the radiesse(+) injection, the patient experienced nodules on the left medial neck and submental around june or july 2023 (as reported).On (b)(6) 2023, the patient wanted to be looked at by another injector and saw the reporter.On (b)(6) 2023 and on (b)(6) 2023, as a corrective treatment, she was injected with 1 ml of hylenex.It appeared that radiesse(+) was placed too deep with only 3 injection points which resulted in too much product placed in one area and was not present for the initial procedure.The patient had an additional follow up at the end of the month.The reporter hoped that the nodule would flatten over time and resolve, but was not sure how long.The outcome of the event nodules on the left medial neck and submental remained unchanged.The outcome of the event too much product placed was unknown.In the opinion of the reporter, the corrective treatment was necessary to prevent permanent damage.The reporter believed that the event happened due to improper placement of the hyper dilute radiesse(+).
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event nodules on the left medial neck and submental (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 a00066940, was reviewed.A lot search was conducted on the reported lot and other similar events were noted.No nonconformances were noted related to this lot.

• 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: 17958917
• Report Number: 3013840437-2023-00109
• Device Sequence Number: 17466716
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K25
• UDI-Public: +M2138063M0K25/$$3240718A00066940C
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/18/2023

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: 07/18/2024
• Device Catalogue Number: 8063M0K2
• Device Lot Number: A00066940
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/18/2023
• Date Device Manufactured: 07/18/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 75 KG