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U.S. Department of Health and Human Services

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

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ANTEIS S.A. BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, cutaneous eruptions/livedo reticularis like rash with pustules (rash pustular), 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: thulesen, j. & storm, m. C. (2021). Iatrogenic loss of vision by aesthetic treatment with filler. The journal of the danish medical association, 183:v09200639, 1-4.
 
Event Description
This mdr is related to mdr 3013840437-2021-00045, 3013840437-2021-00047, and 3013840437-2021-00048 referring to the same patient. This is a literature report presenting a treatment and handling algorithm based on casuistic data for emergency use in catastrophic situation. This literature report from denmark concerns a patient. The patient was injected with hyaluronic acid, as a facial aesthetic treatment. After the treatment with hyaluronic acid the patient experienced vascular compromise with visual loss (considered as permanent damage), also described as severe complications. The outcome of the events was unknown. In the opinion of the authors, prompt and sufficient action for vascular compromise with visual loss was essential. Follow-up information was received on 08-mar-2021: new events blurred vision, blepharoptosis (mild) and diplopia were added. The patients age and gender were provided. The patient was a (b)(6) female patient. She was injected with hyaluronic acid, under both eyes, for the reduction of circles under the eyes. Within two hours after the treatment with hyaluronic acid, the patient experienced right-sided ocular pain, cutaneous edema and discoloration. Through contact to the attending cosmetic clinic by telephone, she was advised to take antihistamines, apply cold compresses and wait and see. After a few hours of subjective deterioration, during which blurred vision, diplopia and cutaneous eruptions occurred, she visited an emergency ward. While waiting, she published an account of her subjective discomfort and photos of her face on social media. Qua feedback to instead find a cosmetic clinic for targeted and acute treatment, she consulted another cosmetic clinic, where due to symptoms and objective findings, including livedo reticularis-like skin rash with pustules, hyaluronidase (1200 units) was administered via a subcutaneous injection in the area treated with filler, on suspicion of arterial embolism. In addition, she was given acetylsalicylic acid and urgently referred to an eye clinic. In objective terms, right-sided blepharoptosis (also reported as mild), as well as a marbled hyperemic skin reaction in the periocular area was found, and in supply areas for the aa. Angularis, dorsalis nasi and supratrochlearis (as reported). In ophthalmological terms, inapparent conditions such as visual acuity, pupillary responses, motility and field of vision were found. Peroral endoscopic myotomy with prednisolone and moxifloxacin was initiated, while treatment with acetylsalicylic acid was continued, in combination with regular consultations, including orthoptic examinations ending after four months, where mild right-sided cutaneous hyperemia in the periocular area, including nasojugal sulcus was found. Conditions were otherwise normal. Due to the provided information, the outcome of the event vascular compromise was considered as and changed from unknown to resolving. Due to the provided information, the outcome of the event visual loss was considered as and changed from unknown to resolved. Due to the provided information, the outcome of the events blurred vision, blepharoptosis (mild) and diplopia was considered as resolved. In the opinion of the authors, the filler product had the possibility to be accidentally injected into an artery, where it migrated to the bloodstream in a retrograde fashion based on the infusion pressure from the treatment providers syringe. When the infusion pressure decreased, the intravascular filler product migrated with the blood in an antegrade fashion until there was an actual embolization in the smallest blood vessels/capillaries, which in the worst case were in a. Centralis retinae. The subjective symptoms typically occurred momentarily and depended on the physical localization of the ischaemic conditions. The symptoms had to lead to a prompt response, preferably within 60-90 minutes of the onset to be effective. When vision loss was diagnosed, the highest priority appeared to be retrobulbar injection of hyaluronidase in large doses (500-1500 units). It was better if the treatment was supplemented with the reduction of intraocular pressure by ocular massage and tension-reducing eye drops to reduce intraocular perfusion resistance.
 
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Brand NameBELOTERO BALANCE
Type of DeviceIMPLANT, 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 Key11486020
MDR Text Key244450005
Report Number3013840437-2021-00046
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeDA
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2021
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: 03/15/2021 Patient Sequence Number: 1
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