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

Catalog Number 8063M4K1

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

This spontaneous report was received from a mexican physician and concerns a (b)(6) year-old female patient (weight (b)(6) kg, height 158 cm). She was injected with a total of 1. 5 ml of radiesse(+), into the nasolabial folds and malar region, as a cosmetic correction, on (b)(6) 2022 (also ambiguously reported as (b)(6) 2021). The batch number was reported as a00031840 (expiry date: 07/2023). A lot search in the global safety database was conducted. The batch record review was received and the lot number for radiesse(+) was confirmed as a00031840 (expiry date: 07/2023). She was injected subcutaneously into the nasolabial folds. The patient received the covid-19 booster vaccination, 3 weeks prior to the radiesse(+) injection, in (b)(6) 2021. On (b)(6) 2022, 6 hours after the radiesse(+) injection, the patient experienced a burning pain in the left cheek. The physician prescribed aspirin protect and the use of warm compresses, which reduced the pain by 50%. On (b)(6) 2022, 24 hours after the radiesse(+) injection, the patient experienced oedema in the same region (left cheek). Since the patient returned to her country of residence, the treating physician instructed her to see another specialist. According to the patient, the new physician gave her injections in her face, which improved her symptoms. Due to the provided information the outcome of the events was considered as resolving. Follow-up information was received on 19-jan-2022: this case was upgraded to serious. The event vascular lesion of the facial artery/ suspected occlusion was added. The events oedema and burning pain were deleted, as they were considered as symptoms of the vascular lesion of the facial artery. It was confirmed that the patient had her second injection of the covid-19 vaccination. Based on the evolution of the signs and symptoms that the patient presented in the following days, the treating physician considered it to be a vascular lesion of the facial artery. The patient presented pain and unilateral oedema, a change in skin colouring in the distribution of irrigation of the facial artery, and the appearance of a crust in the groove on the chin side. The symptoms described corresponded to a vascular lesion (whether compression or embolisation). The physician suspects occlusion due to a faulty injection technique. Corrective treatment included hyaluronidase injections, massage, prednisone, pentoxyphylline, sildenafil, aspirin protect and warm compresses. As reported, the patient was in the contact with the new physician for 6 days. On (b)(6) 2022, the patient presented adequate reperfusion. On (b)(6) 2022, the treating physician was going to discharge her, since the events were considered as resolved. Due to the provided information, the outcome of the event was considered as resolved, on (b)(6) 2022. The treating physician did not believe there was a link to the recent covid-19 vaccination.

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, vascular lesion of the facial artery/suspected occlusion (vascular occlusion) 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 a00031840 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformance's were noted that would have contributed to this event.

• 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: 13359100
• MDR Text Key: 289250128
• Report Number: 3013840437-2022-00008
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8063M4K1
• Device Lot Number: A00031840
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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: 01/26/2022 Patient Sequence Number: 1

Treatment

CONCOMITANT DRUG NOT AVAILABLE