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 Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, progressive bruising (injection site bruising), 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 could not be reviewed as the lot number was not reported.Literature citation: jagus d, skrzypek e, migda b, wozniak w, mlosek rk: usefulness of doppler sonography in aesthetic medicine.J ultrason 2020; 20: e268-e272.Doi: 10.15557/jou.2020.0047.

Event Description

This mdr is related to mdr 3013840437-2021-00026 and 3013840437-2021-00027 referring to the same literature article.This is a literature report from a retrospective study aimed to assess the usefulness of high frequency doppler imaging in the diagnosis of vascular complications after augmentation procedures with tissue fillers.This literature report from poland concerns a (b)(6) female patient.She was injected with hyaluronic acid, into the ridge and the bridge of the nose.Five hours after the treatment with hyaluronic acid, the patient developed reddening and progressive bruising of the nasal and frontal region.Corrective treatment included 1300 units of hyaluronidase, vitamin c, dexamethason, ciprofloxacin and massage.The appearance of the skin improved and a follow-up ultrasound was recommended.No hyaluronic acid deposits were detected on ultrasound, indicating their effective dissolution.The flow in the dorsal nasal arteries was maintained.The outcome of the event was considered as resolved.In the opinion of the author, the skin ultrasound with doppler options is a useful tool in the diagnosis of aesthetic medicine complications.There is a growing interest in dermal ultrasonography among both doctors specialized in dermatology and aesthetic medicine, as well as patients.This creates a need to constantly incorporate new imaging techniques and functions featured by modern ultrasound scanners into dermal ultrasonography.In addition to standard assessment of the epidermis, dermis and subcutaneous tissue, imaging of the vascularity of the examined area should be a crucial element of each examination.Imaging of skin vessels is currently rare, although it has been shown to be extremely useful.

• 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: 11351017
• MDR Text Key: 242883399
• Report Number: 3013840437-2021-00028
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 01/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR