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	Nodule (4551)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event soft lump in neck/ hypodense right thyroid nodule (injection site nodule) was deemed to meet serious injury criteria of disability or permanent damage.The device history record of radiesse injectable implant, lot number a00053290, was reviewed.A lot search was conducted on the reported lot and no similar events were noted.No nonconformances was related to this lot.
Event or Problem Description
This mdr is related to mdr 3013840437-2023-00015 referring to the same patient.This spontaneous report was received from an us nurse and concerns a patient.The patient was injected with radiesse.The batch number was reported as a00053290 (expiry date: 03/2025).The batch record review was received and the lot number for radiesse was confirmed as a00053290 (expiry date: 03/2025).A lot search in the global safety database was conducted.More than 3 months after the radiesse injection, the patient experienced a soft lump in the neck.The patient believed that the aesthetic injection was the cause.About 3 months after the radiesse injection, the patient developed tortuous blood vessels/varicosities.The outcome of the events was unknown.Follow-up information was received on (b)(6) 2023: this case was upgraded to serious.The event term soft lump in neck was amended to soft lump in neck/ hypodense right thyroid nodule, coding remains unchanged.Expectedness for the event tortuous blood vessels/varicosities was reassessed.The patients initials, date of birth, age and weight (58.9 kg) were provided.The patient was 51 years old at the time of the events.The patient was injected with radiesse, into the neck and submental (off label use of device), on (b)(6) 2022.A total of 1.5 ml was hyperdiluted 1:3, with 1.2 ml volume diluted in each area.The patient had no known medical history or prior fillers.No concomitant medications were noted.On (b)(6) 2022, 85 days after the radiesse injection, the patient experienced the events.On (b)(6) 2022, a computerised tomogram (ct scan) done and showed that on the infrahyoid there were curvilinear hypodensities in the subcutaneous tissues of the left anterior neck at the level of the thyroid cartilage deep to the fiducial marker, favored to reflect asymmetrically prominent and tortuous blood vessels.There were multiple curvilinear hyperdensities in the subcutaneous issues of the chin in the submental region, that may reflect pooling of the contrast within prominent vesses versus calcified phleboliths.There was a subcentimeter hypodense right thyroid nodule.The lymph nodes were not pathologically enlarged (for the patients age) or necrotic appearing lymph nodes.On the upper chest and mediastinum (mediatinum) the imaged portion was unremarkable.On the musculoskeletal there was no aggressive osseous lesions or acute osseous abnormality.The conclusion was that there was asymmetrically prominent and tortuous blood vessels in the subcutaneous tissues of the left anterior neck in the region of palpable concern.This was non-specific and possibly reflected varicosities versus a vascular malformation.Cosmetic injections possibly also produced this imaging appearance of there was correlative history.Relevant laboratory tests only included the computerised tomogram.The patient was also seen by an ear, nose, and throat specialist (ent).No treatment measures were given or prescribed.At the time of this report, there was no resolution yet.The reporter spoke to a physician regarding the incident and was going to refer the patient to another colleague but did not hear back.Due to the provided information, the outcome of the events was considered as not resolved (changed from unknown).In the opinion of the reporter, the events were permanent, and it was unknown if they were related to radiesse.The reporters causality was therefore changed from reasonable possibility to not assessable.To the reporters knowledge, no treatment was necessary to prevent a permanent damage.

• 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: 16430046
• Report Number: 3013840437-2023-00016
• Device Sequence Number: 5297827
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K22
• UDI-Public: +M2138071M0K22/$$3250329A000532901
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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: 03/29/2025
• Device Catalogue Number: 8071M0K2
• Device Lot Number: A00053290
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/23/2023
• 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: Disability
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 58 KG