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

Lot Number 326088/1

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

Patient Problem Ischemia (1942)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event disorientation/did not recognize her family members (pt: cerebral ischemia), was deemed to meet the serious criteria of hospitalization.The device history record of belotero balance lidocaine lot number 326088/1 was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.No nonconformances were noted related to this lot.

Event Description

This spontaneous report was received from a (b)(6) physician and concerns a (b)(6) female patient.She was injected with belotero balance lidocaine, into the lip, for lip contouring and lip profiling, on (b)(6) 2022.Batch number was reported as 326088/1.A lot search in the global safety database was conducted.The patient was injected with a 30 g needle.She had no previous aesthetic injections.The patients medical history and known allergies were reported as none.Concomitant medications included irbesartan.On (b)(6) 2022, 3 hours after the belotero balance lidocaine injection, the patient experienced disorientation and she did not recognize her family members.As reported, she showed signs of transient cerebral ischemia.In (b)(6) 2022, the patient was hospitalized and had medical examinations including computed tomography scan and a lumbar puncture.She presented satisfactory results.The patient stayed for 24 hours under medical supervision at the hospital.She was released feeling better.Until (b)(6) 2022, the patient recovered successfully.No adverse events were observed on the lips.Due to the provided information, the outcome of the event was considered as resolved, in (b)(6) 2022.Follow up information was received on (b)(6) 2022: the patient was injected with a total 0.7 ml of belotero balance lidocaine.She was injected with 0.35 ml per side (into 4 injection points per side).The patient had no autoimmune diseases, intake of interferon or omalizumab, or surgical interventions in the past.On (b)(6) 2021, the patient was hospitalized, and continued under medical supervision in the hospital.In the hospital, the patient presented with low blood pressure and bradycardia.No systemic antibiotics were prescribed.The outcome of the event disorientation/ did not recognize her family members remained unchanged.The outcome of the reported low blood pressure and bradycardia was unknown.In the opinion of the reporter, the events were of severe intensity, not life threatening and unknown if permanent.Follow-up information was received on (b)(6) 2022: the batch record review was received and the lot number for belotero balance lidocaine was confirmed as 326088/1 (expiry date 02/2023).

Event Description

Follow-up information was received on 20-may-2022: it was confirmed that concomitant medication at the time of the event included irbesartan.The reporter informed that no corrective treatment was performed and that the patient recovered completely.The outcome of the event remained unchanged.

• Brand Name: BELOTERO BALANCE LIDOCAINE
• Type of Device: IMPLANT, 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 Key: 14208352
• MDR Text Key: 290076539
• Report Number: 3013840437-2022-00055
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 326088/1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IRBESARTAN (IRBESARTAN).
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female