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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 Skin Infection (4544)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, infection (injection site infection) was deemed to meet the serious criteria of required treatment to prevent permanent damage. The device history record could not be reviewed as the lot number was not reported.
 
Event Description
This mdr is related to mdr 3013840437-2022-00026 referring to the same patient. This consumer report was received from a us consumer and concerns a patient. The patient was injected with belotero (not further specified), into the dent of the nose (off label use of device), in spring 2016 (as reported). As reported, the injecting physician, made other mistakes with fillers on the patient. In spring 2016, after the treatment with belotero, the patient experienced that the skin became bright red, as well as black and blue, with bleeding. It was awful. As reported, apparently the physician did the injecting wrongly, hit a larger vein and caused a rupture. The patients nose took a couple years to settle down from the swelling of the huge wound. A scab formed over the wound, and an infection was under it. The injecting physician never gave or instructed the patient to take antibiotics or use topical antibiotics. As reported, the physician said makeup was not going to hurt the wound. When the scab fell off, the patient was left with a much deeper dent then the one the physician was trying to lift with belotero. The dent changed the shape of the patients nose and after visiting 10 too dermatologists (as reported), nothing was done for it. Lasers, microneedling, nothing worked. The dent was too deep. At the time of this report, the patient needed larger plastic surgery, but few doctors were willing to touch the area of skin that was traumatized. Due to the provided information the outcome of the event huge wound was considered as resolved with sequelae. The outcome of the events infection and rupture (vein) was unknown.
 
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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 Key13596232
MDR Text Key290549847
Report Number3013840437-2022-00027
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
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 Received02/17/2022
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: 02/24/2022 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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