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

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

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the adverse event, massive occlusion (vascular occlusion), was deemed to meet the serious injury reporting criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage of a body structure.The device history record could not be reviewed as the lot number was not reported.

Event Description

This spontaneous report was received from a (b)(6) healthcare professional and concerns a female patient, in her early twenties.She was injected with a total of 0.5 ml of radiesse®, into the chin, on (b)(6) 2020.The patient did not experience issues during injection.On (b)(6) 2020, after the treatment with radiesse®, the patient experienced a little bruising (later reported as lots of bruising).On (b)(6) 2020, the patient came back to the clinic and the nurse suspected a vascular occlusion (also reported as massive occlusion, considered as severe).Corrective treatment included flushing with 10 ml of saline.The patient was then treated by another physician, who decided to treat the patient with hylase, saline, viagra and glyceryl trinitrate (gtn) patch.Later that day, the patient experienced pain in the chin and lip and started a vigorous massage.She also experienced blanching on the chin and numbness as the occlusion was radiating to the bottom left hand of the lip.On (b)(6) 2020, in the morning, her capillary refill time was 5 seconds and in the evening it was 3 seconds (improvement).On (b)(6) 2020, the patient was reviewed by the nurse.The pain was reduced and sensation was returning to the chin.There were no signs of infection.The patient was prescribed doltra pain medication 20 mg, viagra 100 mg and peniodiolon 50 mg (7 day course).As reported, the patient was ok and well.Due to the provided information, the outcome of the event was considered as resolving.

• 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
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville, wi
• Manufacturer Contact: product safety ; 6501 six forks road; raleigh, nc ; 5828000
• MDR Report Key: 10368615
• MDR Text Key: 202996937
• Report Number: 3013840437-2020-00070
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 08/05/2020

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
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention