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	Wrinkling (2613)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event, crepey skin (skin wrinkling) was deemed to meet serious injury criteria of causing disability or permanent damage.The device history record for belotero balance lidocaine lot number 326082 was reviewed.A lot search was conducted on the reported lot and no similar events were noted.Nonconformance was noted to this lot, but none that would have contributed to this event.
Event or Problem Description
This mdr is related to mdr 3013840437-2022-00048 referring to the same patient.This spontaneous report was received from a us nurse and concerns a patient.The patient was injected with belotero balance lidocaine us, into the tear trough (off label use of device), around 3 weeks prior to this report, in 2022.The batch record review was received and the lot number for belotero balance lidocaine us was confirmed as 326082 (expiry date: 08/2022).A lot search in the global safety database was conducted.In 2022, around 3 weeks after the belotero balance lidocaine us injection, the patient was still really swollen.Corrective treatment was tried and included antihistamines, oral steroids, ice and lymphatic drainage.The reporter was thinking that she got the right eye in the wrong compartment.Due to the provided information, the outcome of the event was considered as not resolved.Follow-up information was received on 01-apr-2022: this case was upgraded to serious.The event crepey skin was added.The event term was still really swollen was changed to was still really swollen/ undereye swelling/ malar edema, and it was recoded from injection site swelling to injection site edema.The patients date of birth, age, weight (b)(6) and gender (male) were provided.The patient was (b)(6) at the time of the event (ambiguously reported as (b)(6)).He was injected with 0.3 - 0.4 ml per tear trough.The patient had no previous filler treatments.The patients medical history and concomitant medications were reported as none.On (b)(6) 2022, after the belotero balance lidocaine injection, the patient experienced under eye swelling, crepey skin, and new malar edema.The patient was treated with antihistamines, lymphatic drainage, prednisone and tincture of time.The patients condition was essentially unchanged since the onset.An appointment was made for elective reversal.The outcome of the event was still really swollen/ under eye swelling/ malar edema remained unchanged.Due to the provided information, the outcome of the event crepey skin was considered as not resolved.In the opinion of the reporter, the event was permanent and related to belotero balance lidocaine.

• 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: 14087693
• Report Number: 3013840437-2022-00049
• Device Sequence Number: 17472275
• Product Code: LMH
• UDI-Device Identifier: 07640123791138
• UDI-Public: (01)07640123791138(10)326082(17)220804
• 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): 04/12/2022

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: 08/04/2022
• Device Model Number: 8705M0
• Device Catalogue Number: 8705M0
• Device Lot Number: 326082
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/12/2022
• Date Device Manufactured: 02/04/2021
• 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: Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 91 KG