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U.S. Department of Health and Human Services

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

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ANTEIS S.A BELOTERO BALANCE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 356045/1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 02/05/2022
Event Type  Injury  
Event Description
This case was linked to (b)(4), referring to the same patient. This spontaneous report was received from a (b)(6) nurse and concerns a (b)(6) female patient. She was injected, during a training session, with belotero balance lidocaine, into the temples, cheeks, nasolabial and chin, for a full face treatment, on (b)(6) 2022. Batch number was reported as 356045/1 (expiry date: 03/2022). A lot search in the global safety database was conducted. The patient was concomitantly injected with radiesse(+), into the temples, chin, jawline, nasolabial and cheeks, on (b)(6) 2022. Batch number was reported as a00004090 (expiry date: 12/2022). She was also concomitantly injected with belotero volume lidocaine, into the temples, chin, jawline and cheeks, on (b)(6) 2022. Batch number was reported as 557188/1 (expiry date: 05/2023). She was also concomitantly injected with belotero soft lidocaine, into the lips, on (b)(6) 2022. Batch number was reported as 256002/1 (expiry date: 05/2022). She was injected subdermal and subcutaneous, deep at the agonal angle, using a cannula. She received a full face treatment. The patient was injected superficial in the temples with radiesse(+) and belotero balance lidocaine. The patients medical history and concomitant medications were reported as none. She had no relevant aesthetic history or known allergies. On (b)(6) 2022, after the belotero balance lidocaine injection, the patient experienced bruising on the left lower anterior aspect of the lateral mandible/chin, and bruising and discoloration on the upper and lower lip and inside the mouth. The patient contacted the injector 7 hours post treatment. There was no pain or numbness. It was advised to bring in the patient for assessment. The reporter did so with the assistance of (b)(6) via (b)(6) (as reported). There was a good capillary refill. Her lips had an unusual discoloration and purple bruising was noted inside the mouth. It was a vascular compromise in the inferior labial artery, likely due to the filler in the lip. The final diagnosis was made and confirmed by the nurse and a physician. As corrective treatment, the patient was given 300 units of hyaluronidase and oral aspirin. On (b)(6) 2022, the patient had a good circulation and the discoloration in the lips did markedly improved. She was feeling better and happy with the results of hyaluronidase. At the time of this report, the patient fully recovered. No systemic antibiotic was prescribed, and the patient was not hospitalized. The outcome of the event was reported as resolved, in (b)(6) 2022. In the opinion of the reporter, the event was of mild intensity, not life-threatening, not permanent, related to belotero balance lidocaine and not related to the incorporated local anaesthetic. Follow up information was received on 15-feb-2022: the batch record review was received and the lot number for belotero balance lidocaine, was confirmed as 356045/1 (expiry date: 03/2022).
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, vascular compromise (vascular compression) was deemed to meet the serious criteria of required treatment to prevent permanent damage. The device history record of belotero balance lidocaine injectable implant, lot number 356045/1, was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. Nonconformances were noted but none that would have contributed to this event.
 
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Brand NameBELOTERO BALANCE LIDOCAINE
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 Key13560961
MDR Text Key286518039
Report Number3013840437-2022-00017
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number356045/1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/09/2020
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: 02/18/2022 Patient Sequence Number: 1
Treatment
1) RADIESSE (+); 2) BELOTERO VOLUME LIDOCAINE; 3) BELOTERO SOFT LIDOCAINE
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