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

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, itching / rash (pt: rash pruritic) was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not provided.

Event Description

This mdr is related to mdr 3013840437-2021-00125 referring to the same patient.This spontaneous report was received from a us physician and concerns a female patient.She was injected with belotero® balance lidocaine, into the tear troughs (off label use of device).After the treatment with belotero® balance lidocaine, the patient experienced a generalized reaction with swelling and itching, on her arm and all over.The patient went to the emergency room.She received steroids and benadryl with no significant response.After a high dose of steroids, the patient started responding, and after 2 days, the rash was resolving.The outcome of the event itching/ rash was reported as resolving.The outcome of the event swelling was unknown.

• 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: 11920657
• MDR Text Key: 257442947
• Report Number: 3013840437-2021-00140
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2021
• 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
• Patient Outcome(s): Required Intervention