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

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

Patient Problem Nodule (4551)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, nodules, 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 case was linked to mdr 3013840437-2020-00130, referring to the same reporter and the same reaction. This spontaneous report was received from a us physician and concerns a female patient (herself). She was injected with radiesse®, approximately 3 years prior this report. After the treatment with radiesse®, the patient experienced nodules. She tried to massage them, but they never went away. Due to provided information, the outcome of the event was considered as not resolved.

• Brand Name: RADIESSE
• 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 road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 11100357
• MDR Text Key: 224532143
• Report Number: 3013840437-2020-00129
• 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: health professional
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/02/2020
• 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 Treatment Data

Date Received: 12/31/2020 Patient Sequence Number: 1

Treatment

CONCOMITANT DRUG NOT AVAILABLE