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 Date 02/05/2022

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event vascular compromise (pt: vascular compression), was deemed to meet the serious criteria of required treatment to prevent permanent damage. The device history record of radiesse(+) injectable implant, lot number a00004090, 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.

Event Description

This case was linked to lssmv cases number (b)(4) to (b)(4), referring to the same patient. This spontaneous report was received from a canadian nurse and concerns a (b)(6) female patient. She was injected with radiesse(+), into the temples, chin, jawline, nasolabial and cheeks, for a full face treatment, on (b)(6) 2022. An off label use of device was reported. Batch number was reported as a00004090 (expiry date: 12/2022). 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 a00004090 (expiry date: 12/2022). The patient was concomitantly injected with belotero volume lidocaine, into the temples, chin, jawline and cheeks, on (b)(6) 2022. Batch number was reported as 557188/1 (expiry date: 05/2023). She was also concomitantly injected with belotero balance lidocaine, into the temples, cheeks, nasolabial and chin, on (b)(6) 2022. Batch number was reported as 356045/1 (expiry date: 03/2022). She was concomitantly injected with belotero soft lidocaine, into the lips, on (b)(6) 2022. Batch number was reported as 256002/1 (expiry date: 05/2022). She was injected subdermal and subcutaneous, deep at the agonal angle, using a cannula. She received a full face treatment, during a training session. The patient was injected superficial in the temples with radiesse(+) and belotero balance lidocaine. The patients medical history and concomitant medications were reported as none. She had no relevant aesthetic history or known allergies. On (b)(6) 2022, after the radiesse(+) injection, the patient experienced bruising on the left lower anterior aspect of the lateral mandible/chin, and bruising and discoloration on the upper and lower lip and inside the mouth. The patient contacted the injector 7 hours post treatment. There was no pain or numbness. It was advised to bring in the patient for assessment. The reporter did so with the assistance of mac via (b)(6) (as reported). There was a good capillary refill. Her lips had an unusual discoloration and purple bruising was noted inside the mouth. It was a vascular compromise in the inferior labial artery, likely due to the filler in the lip. The final diagnosis was made and confirmed by the nurse and a physician. As corrective treatment, the patient was given 300 units of hylaronidase and oral aspirin. On (b)(6) 2022, the patient had a good circulation and the discoloration in the lips did markedly improved. She was feeling better and happy with the results of hylaronidase. At the time of this report, the patient fully recovered. No systemic antibiotic was prescribed, and the patient was not hospitalized. The outcome of the event was reported as resolved, in (b)(6) 2022. In the opinion of the reporter, the event was of mild intensity, not life-threatening, not permanent, related to radiesse(+) and not related to the incorporated local anaesthetic.

• 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: 13515596
• MDR Text Key: 290274783
• Report Number: 3013840437-2022-00016
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8063M4K1
• Device Lot Number: A00004090
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• 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: 02/11/2022 Patient Sequence Number: 1

Treatment

BELOTERO BALANCE LIDOCAINE; BELOTERO SOFT LIDOCAINE; BELOTERO VOLUME LIDOCAINE