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

Catalog Number 8069M5K1

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, late inflammation (injection site inflammation) was deemed to meet serious injury criteria of necessitated 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 lot number 100128152 and 100125642 were reviewed.A lot search was conducted on both of the reported lots and no other similar events were noted.No nonconformances were noted that would have contributed to this event.Lot no : 100125642.Part no : 8069m5k1.Expiration date : 11/2021.Udi no: (b)(4).

Event Description

This spontaneous report was received from a (b)(6) physician and concerns a (b)(6) female patient.She was injected with a total of 1.6 ml of radiesse, into the lower middle third, on (b)(6) 2021.Batch numbers were reported as 100128152 (expiry date: 02/2022) and 100125642 (expiry date: 11/2021).A lot search in the global safety database was conducted.The batch record reviews were received and the lot numbers for radiesse were confirmed as 100128152 (expiry date: 02/2022) and 100125642 (expiry date: 11/2021).She was injected with 0.8 ml x 2 (as reported), using a cannula at a 1:1 dilution (product preparation issue, off label use of device).As reported, the last dose of the covid vaccine was in (b)(6) 2021.The patient had no other fillings or treatments.The patient's medical history included irritated colon and hta (as reported), without other pathologies.On (b)(6) 2021, 119 days after the radiesse injection, the patient experienced late inflammation at the lower middle third, characterized by burning, heat and local redness, without associated pain.On (b)(6) 2021, the patient was evaluated and after identifying the local inflammation, dacortin 30 mg every 24 hours for 5 days and dacortin 15 mg every 24 hours for 5 days were indicated.The patient reported a fluctuation of inflammation and consultation for further worsening (as reported).It was evolving.At the time of this report, there was persistent inflammation.Due to the provided information, the outcome of the event was considered as not resolved.Follow up information was received on (b)(6) 2022: this case was upgraded to serious.This case was also received from the spanish physician via health authority.The patient was injected with 0.8 ml (right side) of radiesse, into the third and inferior middle of the face, on (b)(6) 2021.Radiesse was diluted at a 1:1 dilution, with 0.2 ml of lidocaine and 0.8 ml of saline solution.The patient was injected with a cannula using a retrotracing technique.On (b)(6) 2021, the patient came to a consultation because she noticed an inflammation.The physician noticed swelling, heat and erythema.After the corrective treatment, the patient showed an apparent improvement in symptoms.In (b)(6) 2022, 1 week prior to this report, the inflammation re-appeared, and the physician prescribed deflazacort 30 mg, every 24 hours, until the medical review that was due to take place on the day of this report.The outcome of the event remained unchanged.

Event Description

Follow up information was received on 14-feb-2022: the physician reported that the corrective treatment with decortin and deflazacort was necessary to prevent permanent damage.The outcome of the event 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 rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 13517661
• MDR Text Key: 289885177
• Report Number: 3013840437-2022-00011
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: M2138069M5K15
• UDI-Public: +M2138069M5K15/$$0222100128152V
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

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 Catalogue Number: 8069M5K1
• Device Lot Number: 100128152
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/24/2022
• 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
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female