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 Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, striking pattern of patchy cutaneous erythema and reticulated foci (injection site erythema), 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: lopez-gonzalez, r., velasco-graue, l., & gutierrez-bravo, r.(2019) complication due to hyaluronic acid filler.24th world congress of dermatology milan 2019.

Event Description

This literature report from (b)(6) concerns a (b)(6) year-old female patient.She was injected with hyaluronic acid.The patient was injected by non-medical personal.On the same day, 90 minutes after the treatment with hyaluronic acid, the patient was admitted to the clinic, with striking pattern of patchy cutaneous erythema and reticulated foci in the distribution of the angular artery.The patient was treated as she had a vascular necrosis.She had follow-up until the wound healed.Due to provided information, the outcome of the event was considered as resolved.In the opinion of the authors, dermal fillers temporarily removed the appearance of rhytids and reduced the depth of skin folds.Even with the most experienced of injectors, adverse effects occurred ranging from mild bruising to severe injection necrosis.Physicians had to be able to treat the severe complication of vascular necrosis and detect impending necrosis after injection of a dermal filler, especially with hyaluronic acid fillers as a specific protocol for treatment after injection necrosis was going to improve the outcome of wound healing.

• 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: 11649009
• MDR Text Key: 261776362
• Report Number: 3013840437-2021-00088
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR