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

Catalog Number 8063M6K1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, migratory arthritis, was deemed to meet serious injury criteria of hospitalization.The device history record for lot#: 100131847 was done.A lot search was conducted on the reported lot, and no similar events were noted.No non-conformances were noted that would contribute to this event.

Event Description

This case was linked to mdr 3013840437-2020-00127, referring to the same patient.This spontaneous report was received from a (b)(6) physician via a sales representative, and concerns a (b)(6)-year-old female patient (height (b)(6) cm, weight (b)(6) kg).She was injected subdermally and subcutaneously, with 1 syringe of radiesse® +, into the face, for a collagen biostimulation, in the afternoon, on (b)(6) 2020.Batch number was reported as 100122571.A lot search in the global safety database was conducted.The patient was concomitantly injected supra-periosteally, with 2 syringes of radiesse into the face and neck, on the same occasion, on (b)(6) 2020.Batch number was reported as 100131847.A needle and a 22g cannula were used for the injections.The patient was previously treated with botulinum toxin and hyaluronic acid in the lips.Further patients medical history included a hypertrophic scar (intentional device misuse).Concomitant medication were reported as none.She had no disposition to lymph drainage problems, allergies, autoimmune diseases, intake of interferon or omalizumab, or surgical interventions in the past.On (b)(6) 2020, approximately 16 hours after the treatment with radiesse®+, the patient experienced arthralgia and purple lesions in the lower limbs, without a fever.Prednisone 40mg was prescribed orally.The patient evolved with an increase in purpuric lesions for the upper limbs, arthritis and epigastric pain.There was no reaction at the injection site.The patient was hospitalized and several laboratory tests were performed to investigate the rheumatological disease.The patient was prescribed ceftriaxone, dexamethasone and omeprazole.She was discharged 36 hours later, with a prescription for clavulin and prednisone at a dose of 40mg a day.At the time of this report, the patient persisted with purpuric lesions and migratory arthritis.As reported, she was going to be seen by a rheumatologist.The outcome of the event epigastric pain was reported as unknown.Due to the provided information, the outcome of the events migratory arthritis was considered as not resolved (reported as unknown).In the opinion of the reporter, the events were not life-threatening, not permanent and related to radiesse ®.Follow-up information was received on 15-dec-2020: the event intentional device misuse was deleted.It was confirmed that the patients medical history did not include a hypertrophic scar.The patients medical history was reported as none.The outcome of the events remained unchanged.

• Brand Name: RADIESSE+ INJECTABLE IMPLANT
• Type of Device: 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 road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 11072338
• MDR Text Key: 224033596
• Report Number: 3013840437-2020-00128
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Catalogue Number: 8063M6K1
• Device Lot Number: 100122571
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 60