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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Swelling (2091); Reaction (2414)
Event Date 02/11/2020
Event Type  Injury  
Event Description
I got juvederm volbella in 2015. I had a reaction in 2018 with swelling and a late inflammatory response this year; it has been debilitating expensive and distressing. I got a virus and then my filler which was supposed to be gone since i got it in 2015, reacted and i have had 21 shots of dissolvent to try to stop the reaction. I also am on two antibiotics and prednisone and i had a ct scan and many dr visits. The ct confirmed that it was filler reacting. Fda safety report id# (b)(4).
 
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Brand NameJUVEDERM VOLBELLA
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key9792991
MDR Text Key182420068
Report NumberMW5093524
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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

Patient Treatment Data
Date Received: 03/04/2020 Patient Sequence Number: 1
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