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 Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, losing her vision (pt: visual impairment), was deemed to meet serious injury criteria of resulted in 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.

Event Description

This consumer report was received from a us consumer and concerns a (b)(6) year-old female patient.She was injected with radiesse®.As reported, she received 1.5 of radiesse®.The patient was severely allergic to shellfish.The patient had radiesse® in the past, since the age of (b)(6) (as reported), and never had a problem.After the treatment with radiesse®, the patient experienced some type of an allergic reaction.The filler moved.It seemed to move into the patient's left eye socket.She had daily swelling in the eyes, and peeling.The patient was losing her vision in the good eye, and wanted to know what the chances were that it was from the product.The patient wanted to know if the product contained shellfish, and if the product possibly moved with a heavy ice pack for two weeks.The patient wanted radiesse® removed and redone, if it did not contain shellfish.As reported, she was going to have an appointment to have it removed and hopefully put back in, on (b)(6) 2021.On (b)(6) 2021, the patient also had an appointment with an ophthalmologist.The patient took an eye antibiotic (reported as anabiotic).At the time of this report, she had a 60% improvement.As reported, it was not clearing up in the bump on her eye that was still there.The patient was going on an overall antibiotic, in case radiesse® held an infection.She did not want to spread it through her body.As reported, the patient was possibly allergic to bees, and if she was, she was not going to be able to get it dissolved.Reportedly, the patient needed a test on the forearm.As reported, the injector was going to dissolve radiesse® from her face property, the week of this report.The patient wanted a prescription for an x-ray.Due to the provided information, the outcome of the events losing her vision, allergic reaction and filler moved was considered as resolving.The outcome of the event bump on her eye was considered as not resolved.

• 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: 11658450
• MDR Text Key: 262864605
• Report Number: 3013840437-2021-00099
• 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: consumer
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 50 YR