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

Model Number 8063M0K1

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event possible 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 a00030730 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 spontaneous report was received from a us physician and concerns a 37-year-old male patient.He was injected with a total of 3 ml of radiesse(+), into the right jowl area (off label use of device), one day prior to this report, on (b)(6) 2022.Batch number was reported as a00030730 (expiry date: 09/2023).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 a00030730 (expiry date: 09/2023).He was injected with two, 1.5 syringes.In (b)(6) 2022 after the radiesse(+) injection, the patient experienced a possible occlusion.On (b)(6) 2022, in the morning of this report, the patient sent pictures of his face and it appeared that he had an occlusion, extending from his chin to his lip, on the right side of his face.The health care professional instructed the patient to take aspirin and apply hot compresses.Once the patient arrived at the spa, they were going to apply a nitric paste in the affected area.The outcome of the event was unknown.Follow-up information was received on (b)(6) 2022: the patient was injected with radiesse(+), into the chin, on (b)(6) 2022.On (b)(6) 2022, the patient contacted the med spa and reported that his top lip was turning purple with pain and discoloration of the top lip.The injector realized it was a possible occlusion and concerned asked the patient to come in.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: 15182272
• MDR Text Key: 297412210
• Report Number: 3013840437-2022-00100
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Public: +M2138063M0K15/$$3230907A00030730+
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: 8063M0K1
• Device Catalogue Number: 8063M0K1
• Device Lot Number: A00030730
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Date Device Manufactured: 09/07/2021
• 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: 37 YR
• Patient Sex: Male