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

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

Patient Problem Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, infection (injection site infection) was deemed to meet the serious criteria of required treatment to prevent permanent damage. The device history record could not be reviewed as the lot number was not reported.

Event Description

This mdr is related to mdr 3013840437-2022-00026 referring to the same patient. This consumer report was received from a us consumer and concerns a patient. The patient was injected with belotero (not further specified), into the dent of the nose (off label use of device), in spring 2016 (as reported). As reported, the injecting physician, made other mistakes with fillers on the patient. In spring 2016, after the treatment with belotero, the patient experienced that the skin became bright red, as well as black and blue, with bleeding. It was awful. As reported, apparently the physician did the injecting wrongly, hit a larger vein and caused a rupture. The patients nose took a couple years to settle down from the swelling of the huge wound. A scab formed over the wound, and an infection was under it. The injecting physician never gave or instructed the patient to take antibiotics or use topical antibiotics. As reported, the physician said makeup was not going to hurt the wound. When the scab fell off, the patient was left with a much deeper dent then the one the physician was trying to lift with belotero. The dent changed the shape of the patients nose and after visiting 10 too dermatologists (as reported), nothing was done for it. Lasers, microneedling, nothing worked. The dent was too deep. At the time of this report, the patient needed larger plastic surgery, but few doctors were willing to touch the area of skin that was traumatized. Due to the provided information the outcome of the event huge wound was considered as resolved with sequelae. The outcome of the events infection and rupture (vein) was unknown.

• Brand Name: BELOTERO BALANCE
• 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: 13596232
• MDR Text Key: 290549847
• Report Number: 3013840437-2022-00027
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 02/24/2022 Patient Sequence Number: 1

Treatment

CONCOMITANT DRUG NOT AVAILABLE