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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN JUVEDERM VOLBELLA 1ML SYRINGE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN JUVEDERM VOLBELLA 1ML SYRINGE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 11/13/2020
Event Type  Injury  
Event Description
Reporter called to report her son's adverse inflammatory reaction after a juvederm volbella implant treatment. Reporter stated her son had the treatment on november 13, and he is still dealing with the adverse as of to date. He had the implant on tear trough area, the skin under his eyes to get rid of eye bags. Reporter said on november 19th, 6 days after the treatment his eyes started to burn to an extreme degree. She said he has been to er for his situation. Reporter said she also took her son to an ophthalmologist who prescribed him with prednisone and his condition is improving a little bit.
 
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Brand NameJUVEDERM VOLBELLA 1ML SYRINGE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key10945787
MDR Text Key220003776
Report NumberMW5098208
Device Sequence Number1
Product Code LMH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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