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U.S. Department of Health and Human Services

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

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MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 8071M6K1
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 3013840437-2020-00128, 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 173 cm, weight (b)(6) kg). She was injected subdermally and subcutaneously, with 2 syringes of radiesse¿, into the face and neck, for a collagen biostimulation, in the afternoon, on (b)(6) 2020. Batch number was reported as 100131847. A lot search in the global safety database was conducted. The patient was concomitantly injected supra-periosteally, with 1 syringe of radiesse(+)¿, into the face, on the same occasion on (b)(6) 2020. Batch number was reported as 100122571. 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.
 
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Brand NameRADIESSE INJECTABLE IMPLANT
Type of DeviceIMPLANT, 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 Key11072336
MDR Text Key224035983
Report Number3013840437-2020-00127
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Catalogue Number8071M6K1
Device Lot Number100131847
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/24/2020 Patient Sequence Number: 1
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