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

Model Number	8063M0K1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the case was assessed as reportable to the us fda as the event of post inflammatory hard to palpate nodules was deemed to meet serious injury criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for radiesse(+) dermal filler lot number 100118896 was reviewed.No nonconformances were noted that would have contributed to these events.A lot search was conducted on the reported lot number and there were no previous reports of this event on this lot number.
Event or Problem Description
This spontaneous report was received from a physician's assistant (pa) via merz customer solutions concerning a (b)(6) year old female patient who received radiesse(+).Relevant medical history and concomitant medications were not reported.On (b)(6) 2019, the patient was injected with an unspecified amount of radiesse(+) in the cheeks.On an unspecified date post injection, the patient experienced post inflammatory, hard to palpate nodules.The patient was treated with doxycycline and prednisone.The nodules resolved on an unspecified date during treatment with prednisone.However, when treatment with prednisone was stopped, the nodules returned.Causality was unknown.Follow up information was received on 24 september 2019 from the reporter: the patient had no known drug allergies (nkda) and no history of medical illnesses.There were no relevant concomitant medications.The patient was injected with 2 syringes, 3ml, of radiesse(+).On (b)(6) 2019 the patient experienced moderate swelling to the area of injection one (1) month after injection which, when palpated, was firm and tender.The patient was seen by an ear, nose and throat (ent) at which time a computed tomography (ct) scan of the sinuses was done.No results were provided.Treatment included levaquin and additional prednisone.The reporter stated that she was unable to contact the patient.At the time of reporting, the event was not resolved.It was unknown if the event was considered permanent; however, the reporter assessed that treatment was necessary to prevent permanent damage.In the opinion of the reporter, the event was related the use of radiesse(+).

• 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
• MDR Report Key: 9131570
• Report Number: 3013840437-2019-00002
• Device Sequence Number: 11395251
• Product Code: LMH
• UDI-Device Identifier: M2138063M0K15
• UDI-Public: +M2138063M0K15/$$32103271001188963
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 03/27/2021
• Device Model Number: 8063M0K1
• Device Catalogue Number: 8063M0K1
• Device Lot Number: 100118896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR