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U.S. Department of Health and Human Services

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

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ANTEIS S.A. BELOTERO BALANCE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameBELOTERO BALANCE LIDOCAINE
Type of DeviceIMPLANT, 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 Key11920657
MDR Text Key257442947
Report Number3013840437-2021-00140
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
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: 06/02/2021 Patient Sequence Number: 1
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