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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 Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
This literature report from indonesia concerns a (b)(6) female patient. She was injected with hyaluronic acid, into the nose (intentional device misuse), in an attempt for a higher nose tip. Her medical and social histories were unremarkable. After the hyaluronic acid injection, the patient experienced a vascular occlusion. A few weeks after the injection, the patient arrived at a clinic for a consultation regarding a nose implant. Inflammation with blanchable erythema on the nasal tip was evident upon inspection with slight tenderness upon palpation. The laboratory results were unremarkable. The patient was diagnosed with a post-filler vascular occlusion. The implant procedure was cancelled due to the risk of infection from both the filler and implant being present in the same area. Ninety minute-hyperbaric oxygen therapy sessions, at 2. 4 ata (atmospheres absolute), were administered twice weekly to improve vascularization into the nasal region. The wounds were frequently monitored to evaluate the healing progress. Hyperbaric oxygen therapy was administered along with antibiotics to aid the vascularization of ischemic tissue on the nose. One month later, the patients nose appeared vibrant red with less discoloration indicating enhanced blood flow to the nasal area. Due to the provided information, the outcome of the event was considered as resolving. In the opinion of the authors the most common mechanism of vascular occlusion was an intravascular embolism, which was indicated by pain, blanching, livedo pattern, delayed capillary refill time, blue or greyish discoloration and coolness of the occluded area. The recommended treatments for vascular compromise included firmly massaging the affected area, warm compression, aspirin, hyaluronidase injection and, specifically post hyaluronic acid injection, antibiotics and hyperbaric oxygen therapy as an added treatment option. Hyperoxygenation triggered local cell metabolism and promoted recovery of cellular function thereby increasing fibroblast proliferation, microvascular repair, and capillary angiogenesis. The release of reactive oxygen species and vascular endothelial growth factor played a significant role in this case. These helped to improve microcirculation, promote wound healing, and control infections.
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular occlusion (vascular occlusion) was deemed to meet serious criteria of required 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: oley, m. H. , oley, m. C. , mawu, f. O. , aling, d. M. R. , faruk, m, (2022) hyperbaric oxygen therapy in managing minimally invasive aesthetic procedure complications: a report of three cases, 63-68, https://doi. Org/10. 2147/ccid. S344408.
 
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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 Key13500092
MDR Text Key290097278
Report Number3013840437-2022-00014
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received02/02/2022
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: 02/09/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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