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

Catalog Number 8071M26K1

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

Patient Problem Angioedema (4536)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, angioedema (pt: angioedema) 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 for radiesse lot number a00006550 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformances were noted that would have contributed to this event.

Event Description

This spontaneous report was received from a russian physician and concerns a (b)(6) year-old female patient. She was injected subcutaneously, with a total of 1. 5 ml of radiesse®, into the lower and middle third of the face, for tired morphotype of aging, dermatoporosis and ptosis of the soft tissues of the face, on (b)(6) 2021. The batch number was reported as a00006550. A lot search in the global safety database was conducted. The patient was injected with 0. 75 ml into 4 injection points per side. Needle used for injection was a 25 g cannula. The patient had a laser rejuvenation procedure, one month prior to this report, in (b)(6) 2021. Further patients medical history was reported as none. Concomitant medication included per os colloidal silver solution. She had no disposition to lymph drainage problems, no allergies, autoimmune diseases, intake of interferon or omalizumab, or surgical interventions in the past. Glogau classification was reported as iii. On (b)(6) 2021, after the treatment with radiesse®, the patient experienced an angioedema in the face area. The patient was taken to the hospital by ambulance. As corrective treatment, the patient was given intramuscularly, a solution of dexamethasone (16 mg). The edema significantly decreased in the background of the ongoing therapy. No systemic antibiotic was prescribed. Due to the provided information, the outcome of the event was considered as resolving (reported as not resolved). In the opinion of the reporter, the event was of severe intensity, not life-threatening, unknown if permanent and related to radiesse®.

• 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: 11968128
• MDR Text Key: 255180105
• Report Number: 3013840437-2021-00141
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8071M26K1
• Device Lot Number: A00006550
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 06/09/2021 Patient Sequence Number: 1

Treatment

SILVER (SOLUTION)