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

Catalog Number 8700M0

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

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, edema, was deemed to meet serious injury criteria of permanent impairment of a body function or permanent damage to a body structure.

Event Description

This mdr is linked to mdr 3013840437-2020-00078, referring to the same patient and same reporter.This spontaneous report was received from a us health care professional and concerns a female patient of an unknown age.She was injected during a training session with belotero® (not further specified), into the tear troughs (off label use of device), on (b)(6) 2019.The immediate after results were optimal.In (b)(6) 2019, within a few days after the treatment with belotero®, the patient experienced edema.She was brought in for a follow up and was told to keep her head elevated and ice occasionally.Upon her follow up, no improvement was noted.She was given lumiere eye cream and dissolving was discussed.According to the medical director, dissolving was not recommended due to the proximity to the eye.At the time of this report, the patient was almost 1 year post treatment and had no resolution.She was unhappy with the appearance and also had an area adjacent to her lateral canthus that was permanently bruised according to the patient.It was not apparent in photographs, but noticeable in person.The reporter wanted some insight on the situation.The patient had permanent damage.Due to the provided information, the outcome of the events edema and permanently bruised was considered as not resolved.

Manufacturer Narrative

The device history record for belotero balance lot 321350 was conducted.Non-conformances were found but none that would contribute to this event.A lot search was performed on the reported lot and no similar events were noted.

Event Description

This case is linked to mdr 3013840437-2020-00078 fu1, referring to the same patient.Follow-up information was received on 26-aug-2020: event term edema was changed to edema / bilateral pale and skin coloured orbital edema.The patients date of birth was provided.The patient was (b)(6) at the time of the event.She was injected with total of 2 ml of belotero balance us®.Batch number was reported as 321350.A lot search in the global safety database was conducted.The patient had no prior history with fillers.In 2019, several days or weeks after the treatment with belotero balance us®, the patient developed bilateral pale and skin coloured orbital edema, which was initially suggestive of seasonal allergic edema.The patient reported seeking a second opinion from a dermatologist after more time had passed, without significant improvement.Hyaluronidase was brought up as one option by dermatologist, but the patient stated that she was told that any effect was unlikely, so it was not administered during that visit.It was confirmed that peri/ intra-orbital hyaluronidase was discussed and discouraged at the reporters office because of the location, amount of time passed and course, which was not suggestive of acute bilateral vascular or lymph obstruction.Possible chronic lymph drainage issues and hemosiderin accumulation (ambiguously reported as possible hemosiderin) were suspected.The patient has not been evaluated since (b)(6) 2019, as she has not returned to the reporters facility.As per reporter, it seemed that an unknown amount of the edema persisted.The outcome of the events remained 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
• MDR Report Key: 10454019
• MDR Text Key: 204457557
• Report Number: 3013840437-2020-00077
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: 8700M0
• Device Lot Number: 321350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE; CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Disability
• Patient Age: 53 YR
• Patient Weight: 66