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

Model Number	8705M0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report was received from a us health care professional and concerns a female patient.She was injected with belotero balance lidocaine us, into the lip lines (off label use of device).Batch number was reported as 326141 (expiry date: 09/2023).A lot search in the global safety database was conducted.The batch record review was received and the lot number for belotero balance lidocaine us was confirmed as 326141 (expiry date: 09/2023).After the belotero balance lidocaine us injection, the patient experienced a nodule.The health care professional was suspicious of a vascular occlusion and dissolved it with a hyaluronic acid (ha) antidote.The outcome of the events was unknown.
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event vascular occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for belotero balance lidocaine, lot number 326141, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.Nonconformances were noted related to the reported lot, but none that would have contributed to this event.

• Brand Name: BELOTERO BALANCE LIDOCAINE
• Common Device Name: 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: 16769795
• Report Number: 3013840437-2023-00042
• Device Sequence Number: 3140155
• Product Code: LMH
• UDI-Device Identifier: 07640123791138
• UDI-Public: (01)07640123791138(10)326141(17)230911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P090016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 8705M0
• Device Catalogue Number: 8705M0
• Device Lot Number: 326141
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT DRUG NOT AVAILABLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female