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 Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, throat started swelling shut, was deemed to meet serious injury 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 provided.

Event Description

This consumer report was received from a us consumer and concerns a patient. The patient was injected with radiesse(r), into the marionette lines. Within an hour after from the treatment with radiesse(r), the patients throat started swelling shut. The patient left the office and had a one hour drive home. Upon arrival home, the patient took benadryl and continued to take it all night. The patient called the nurse in the morning and an antibiotic was prescribed. The swelling started to diminish. Due to 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 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: 11038724
• MDR Text Key: 222631555
• Report Number: 3013840437-2020-00123
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 11/19/2020
• 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: 12/18/2020 Patient Sequence Number: 1