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

Lot Number 29840

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/19/2022

Event Type  Injury  

Event Description

This spontaneous report was received from a us healthcare professional and concerns a patient.The patient was injected with radiesse(+), into the cheeks (off label use of device), the day of this report, on (b)(6) 2022.Batch number was ambiguously reported as 29840.On (b)(6) 2022, after the treatment with radiesse(+), the patient experienced blanching and was bruised.It was further described as a possible occlusion (reported as inclusion).The outcome of the event was unknown.

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, possible occlusion (vascular occlusion) 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 could not be reviewed as the lot number was not reported.Batch number was ambiguously reported as 29840.

• Brand Name: RADIESSE (+) INJECTABLE INPLANT
• 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: 14194151
• MDR Text Key: 289980392
• Report Number: 3013840437-2022-00061
• Device Sequence Number: 1
• Product Code: LMH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 29840
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• 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