FDA.reportPublic FDA data

MAUDE MDR 1293708

MDR report key
1293708
Report number
MW5009635
Event key
0
Event type
3
Date of event
2008-11-24
Date received
2009-01-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOVIELLE, VS GELVF GEL REGULATION # 21 CFR 874.3620 CLASS IICO APT SYSTEM INC.MIX24001 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-01-150

Event Narratives#

D

Patient 1

I WAS INJECTED WITH A FILLER IN THE NASAL LABIAL FOLDS AND MARIONETTE LINES THAT I THOUGHT WAS HYALURONIC ACID AND SIGNED A CONSENT TO JUVEDERM. A DAY LATER WENT OUT OF THE COUNTRY AND HAD AN ALLERGIC REACTION TO THE PRODUCT WITH REDNESS, SWELLING, BURNING PAINFUL CYSTS. I RETURNED TO THE MD AND HE TRIED TO REMOVE THE PRODUCT WITH A NEEDLE AND GAVE ME A SCRIPT FOR PREGNZONE, A WEEK LATER, MY LOWER FACE STARTED TO SWELL SO I RETURNED TO MD AND HE ATTEMPTED TO REMOVE MORE PRODUCT. ONE WEEK LATER, I RETURNED BECAUSE OF BURNING AND PRESSURE AS WELL AS ANOTHER ONE WEEK LATER. I HAVE SCARRING, GRANULOMAS, REDNESS AND PAINFUL AREA THAT ARE LIKE CYSTS. DATES OF USE: 2008 (CURRENT). DIAGNOSIS OR REASON FOR USE: DERMAL FILLER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: NO. PRODUCT THERAPY DATES: LATE 2008.