MAUDE Adverse Event Report: ANTEIS S.A. BELOTERO BALANCE; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problem Deposits (1809)

Event Type  Injury  

Manufacturer Narrative

This case has been assessed as reportable to the fda, as the event postseptal hyaluronic acid (pt: product distribution issue), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for belotero balance could not be reviewed, as the lot number was not provided.Master, m.(2021).Novel treatment of inadvertent injection of postseptal hyaluronic acid filler.Plastic and reconstructive surgery, 855e - 856e.Doi: 10.1097/prs.0000000000008465.

Event Description

This case was linked to (b)(4), referring to the same literature article.This is a literature report from a study aimed to demonstrate a novel approach using magnetic resonance imaging to identify and treat inadvertent postseptal complications of hyaluronic acid tear tough treatment.This literature report from australia concerns a (b)(6) female patient.She was injected with hyaluronic acid, into the cheeks and tear toughs (off label use of device).The patient had multiple hyaluronic acid injections over the years.After the hyaluronic acid injection, the patient experienced that magnetic resonance imaging showed postseptal hyaluronic acid.Ultrasound-guided injection of hyaluronidase was performed.A 25-gauge needle was inserted in the postseptal component under ultrasound guidance with 80 to 100 units of hylase.The intralesional ultrasound-guided injection of 80 to 100 units of hyaluronidase (ultrasound-guided injection) was performed with an ultrasound scanner and an 18-mhz, high-frequency probe.All magnetic resonance imaging scans and ultrasound-guided procedures were interpreted and performed by one dual trained aesthetic physician and radiologist with more than 16 years of specialist experience.There was a complete clinical response within 2 to 3 weeks.Due to the provided information, the outcome of the event was considered as resolved.In the opinion of the author, as hyaluronic acid breaks down, because of its hydrophilic nature, it had the possibility to attract more water.This possibly explained the delayed presentations following tear trough treatment.Retrospectively, a lower dose closer to 10 to 20 units of hyaluronidase was possibly more appropriate.Magnetic resonance imaging was used successfully to identify candidates for ultrasound-guided injection of hyaluronidase to dissolve inadvertently injected, postseptal, intraorbital hyaluronic acid filler.This novel technique was possibly going to help avoid oculoplastic corrective surgery.Follow-up information was received on 20-dec-2021: the physician stated that the brand name of the products was unknown in some of the cases as per article and that belotero was not mentioned by the injector or the patient involved.The physician also stated that company products administration was not excluded.The outcome of the event was left unchanged.

• Brand Name: BELOTERO BALANCE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• Manufacturer (Section G): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 13084523
• MDR Text Key: 286673650
• Report Number: 3013840437-2021-00255
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female