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

Model Number	8700M0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as serious and reportable to the fda as the events, blanching, darkening, lip purple (representing a vascular event), were deemed to meet serious injury criteria of necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for belotero dermal filler lot 321330 was reviewed.A lot search was conducted on the reported lot and no similar events were noted.
Event or Problem Description
On (b)(6) 2018, a (b)(6) year old female patient was injected with 0.3cc of belotero to under the eyes.Lot 321330 (expiry 11/30/2019).Medical history positive for injections of radiesse, belotero, volbella, voluma, and juvederm since 2013.Concomitant medications reported as none.Immediately after injection with belotero, the patient experienced blanching down the cheeks to the lip and onto side of nose.Her lip was purple.Corrective treatment reported as hyaluronidase 2cc, nitropaste, and hot compresses.Within one hour, the blanching resolved and the lip color and perfusion were back to normal.In the opinion of the reporter, the events were related to belotero.Follow up information was received from the reporter on (b)(6) 2019: the case was upgraded to serious.In the opinion of the reporter, treatment was medically necessary to prevent damage and tissue necrosis to the patient's face.The patient experienced significant darkening and blanching, moving across the area.Treatment was performed for an hour or so, until the tissue perfusion returned to normal.

• Brand Name: BELOTERO BALANCE
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• MDR Report Key: 8902277
• Report Number: 2135225-2019-00074
• Device Sequence Number: 13516255
• Product Code: LMH
• UDI-Device Identifier: M2138700M05
• UDI-Public: +M2138700M05/$$31911303213301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: 11/30/2019
• Device Model Number: 8700M0
• Device Catalogue Number: 8700M0
• Device Lot Number: 321330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 54