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U.S. Department of Health and Human Services

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

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ALLERGAN JUVEDERM VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 12/08/2020
Event Type  Injury  
Event Description
On (b)(6) 2020 i was injected with one syringe of juvederm volbella. Starting in (b)(6), granular nodules appeared on my chin and spread to my cheeks and the orbital rims of my eyes. Two dermatologists who i saw for treatment told me they had already notified allergan (producers of juvederm volbella) that the product migrates and should be taken off the market. Since (b)(6) i have been treated with prednisone and injections of hyaluronidase. New nodules keep appearing. Allergan has provided no help in response to my questions about how long lasting and possibly dangerous this condition might be. Their response is that they do not provide treatment and to see a physician. My own research uncovered numerous articles about the migration of volbella filler. Did the problem stop after the person reduced the dose or stopped taking or using the product? no. Filler.
 
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Brand NameJUVEDERM VOLBELLA
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key11372626
MDR Text Key233738887
Report NumberMW5099599
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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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