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

Catalog Number 8071M5K1

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event inflammatory reaction (pt: injection site inflammation), was deemed to meet the serious criteria of permanent damage.The device history record for radiesse injectable implant, lot numbers a00028800 and a00031120, were reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted that would have contributed to this event.Lot no - a00031120, part/catalog no - 8071m26k1, udi no - (b)(4), exp date - 08/2023, manufacture date - 09/09/2021.

Event Description

This mdr is related to mdrs 3013840437-2022-00019 and 3013840437-2022-00020, referring to the same patient.This spontaneous report was received from a (b)(6) physician and concerns a (b)(6) male patient.He was injected with radiesse, in the cheeks, on (b)(6) 2021.Batch number was reported as a00028800 (expiry date: 07/2023).A lot search in the global safety database was conducted.The batch record review was received and the lot number for radiesse was confirmed as a00028800 (expiry date: 07/2023).He was later injected with radiesse, in the cheeks, on (b)(6) 2021 (reported as (b)(6) 2022).Batch number was reported as a00031120 (expiry date: 08/2023).A lot search in the global safety database was conducted.The batch record review was received and the lot number for radiesse was confirmed as a00031120 (expiry date: 08/2023).As reported, the patient was injected dermally with a total of 3 ml (1.5 ml into each side, into 3 injection points per side).The needle used in the procedure was a 27g -20 mm.The patient had no relevant medical history.He had no drug allergies, prior treatment with interferon, surgical interventions, previous filler products or aesthetic treatments.He was a non-hypertensive, non-diabetic, without cardiac and respiratory pathology.Concomitant medications were reported as none.In 2021, after the radiesse injection, the patient experienced an inflammatory reaction and product encapsulation on the right and left cheeks.On (b)(6) 2021, the patient reported the inflammation, and prednisone 30 mg every 12 hours was prescribed.On (b)(6) 2021, the patient was better but had indurated areas, and the presence of areas of inflammation in the cheeks was confirmed.Celestone was administered at the affected site, and the patient continued the treatment with prednisone 30 mg.On (b)(6) 2021, 1/2 vial of celestone was administered and the area decreased in size.Prednisone every 24 hours was prescribed.On (b)(6) 2022, 1/4 vial of celestone was administered and prednisone started to be gradually withdrawn in 2 weeks (1/2 every 24 hours, and later 1/2 every 48 hours).On (b)(6) 2022, the patient presented lesions of hard consistency in both inframalar regions.The patient was again intralesionally injected with celestone.He was prescribed to receive radiofrequency after 5 days.On (b)(6) 2022, the patient received treatment with sodium thiosulfate, with 0.4 ml in the left nodule and 0.3 ml into the right nodule.The reporter mentioned that the nodules decreased but did not disappear.The patient was not hospitalized.Due to the provided information, the outcome of the event product encapsulation/ nodules/ lesions was considered as resolving.The outcome of the events inflammatory reaction and indurated areas/ hard was unknown.In the opinion of the reporter, the events were of moderate intensity, permanent and not life-threatening.The physician suspected that there was a causal relationship between radiesse and the event.

• 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: 13543248
• MDR Text Key: 290137709
• Report Number: 3013840437-2022-00018
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: M2138071M5K15
• UDI-Public: +M2138071M5K15/$$0723A00028800
• 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
• Report Date: 02/16/2022

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: 8071M5K1
• Device Lot Number: A00028800
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/16/2022
• Date Device Manufactured: 08/21/2021
• 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): Disability
• Patient Age: 47 YR
• Patient Sex: Male