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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN, INC. JUVEDERM VOLLURE XC IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN, INC. JUVEDERM VOLLURE XC IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 07/13/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 and (b)(6) 2018 i had vollure juvederm filler injected by a very highly qualified and recommended medical dr. It was injected around my lips as well as around my nose and areas around my mouth. I started to feel my lips were hard and looking very enlarged and very uncomfortable feeling. A few weeks later, i started to develop very noticeable pea size bumps, some slightly larger bumps. They appeared all over where the vollure had been injected. It had gotten so bad, my dr had to give me an rx for prednisone. I have been seeing my dr once a week, so she can try to dissolve the filler. Which has been extremely tasking chore as well as painful and stressful. We are finally making some progress with the swelling and trying to dissolve the vollure juvederm. I have heard there is other people who are having the same reaction. Want to make sure nobody has to go through what i have been suffering and dealing with. Date the person started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018. Reason for use: cosmetic filler.
 
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Brand NameJUVEDERM VOLLURE XC
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN, INC.
MDR Report Key8038040
MDR Text Key126272189
Report NumberMW5081043
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 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2018
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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