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

Catalog Number 8063M21

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

This mdr is related to mdr 3013840437-2022-00096, referring to the same patient.This spontaneous report was received from a singaporean physician and concerns a 27-year-old female patient (weight 40 kg).She was injected with radiesse(+), for acne scars, on (b)(6) 2022.Batch number was reported as a00037630 (expiry date: 11/2023).A lot search in the global safety database was conducted.Radiesse(+) was diluted 1:1, with 2% lidocaine (product preparation issue, off label use of device) and the subcision was performed under aseptic technique with a 27g needle.The patient concomitantly underwent radiofrequency micro needling with secretrf, on (b)(6) 2022.The patients medical history was reported as none.On (b)(6) 2022, 3 days after the radiesse(+) injection, the patient experienced severe pain, swelling and redness of left cheek.She was reviewed in the clinic and diagnosed with a skin infection, cellulitis.She was treated with broad spectrum antibiotics, immediately with an intramuscular injection of 1 g of ceftriaxone, and with oral augmentin, 1 g twice a day, for a week.On (b)(6) 2022, the patient reported persistent symptoms and she was referred to a plastic surgeon.She was diagnosed with a microvascular occlusion of the left cheek skin.Antibiotics were continued, and oral prednisolone and oral aspirin were added.There was ongoing follow up for wound care.The outcome of the events was reported as not resolved.In the opinion of the reporter, the events were possibly related to radiesse(+).Follow-up information was received on (b)(6) 2022: the patient was previously injected with rejuran s, in 4 sessions, and they were uneventful.Further patients medical history, know allergies and concomitant medications were reported as none.At the time of this report, the patients condition appeared to be resolving slightly, but the patient was awaiting a review from a plastic surgeon on (b)(6) 2022.For now, no further corrective treatment was planned.Due to the provided information, the outcome of the events was considered as resolving (changed from not resolved to resolving).In the opinion of the reporter, treatment with antibiotics, prednisolone and aspirin was necessary to prevent worsening of the infection and vascular compromise.Follow-up information was received on 21-jul-2022: the batch record review was received and the lot number for radiesse(+) was confirmed as a00037630 (expiry date: 11/2023).The outcome of the events remained unchanged.

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event microvascular occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record of radiesse(+) injectable implant, lot number a00037630, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted.

Event Description

This mdr is related to mdr 3013840437-2022-00096 referring to the same patient.Follow-up information was received on 18-aug-2022: the plastic surgeon referred the patient to a dermatologist for a laser treatment and she was recovering well.The plastic surgeon discharged the patient, however, he was still in touch and was managing the patient well at this junction.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 rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 15115581
• MDR Text Key: 296747521
• Report Number: 3013840437-2022-00095
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: M2138063M215
• UDI-Public: +M2138063M215/$$3231106A00037630L
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2023
• Device Catalogue Number: 8063M21
• Device Lot Number: A00037630
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Date Device Manufactured: 11/06/2021
• 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): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 40 KG