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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Inflammation (2443); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The events of blood running into patient's mouth, patient's mouth felt like it was on fire and their tongue burned, and patient's teeth and mouth hurt are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported events as follows: warnings: "juvéderm® ultra injectable gel must not be injected into blood vessels. Introduction of juvéderm® ultra injectable gel into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur. Injection procedure reaction to juvéderm® ultra injectable gel has been observed as consisting mainly of short-term inflammatory symptoms starting early after treatment and with less than 7 days¿ duration. " adverse events per table 1: injection-site responses by maximum severity occurring in (b)(4) ) possible injection site responses post injection with juvéderm® ultra include redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration.
Event Description
Patient reported after injection with juvéderm® "3 years ago" to correct a "swoop in the nose" they developed ¿side effects¿. The patient reported experiencing the following symptoms: "inability to live, near death, doctor hit a nerve during injection causing blood to run into my mouth, a week after injection my mouth felt like it was on fire and my tongue burned, diagnosed with sinusitis by a local doctor, sinuses are plugged, unable to breathe through the nose which is causing a panic, face feels tight, inability to move jaw, mouth clenches, neck is tight, the issues are now affecting my heart, unable to sleep for a year, now unable to sleep for more than three hours, i think i had a stroke, swoosh in neck and head after the stroke, inability to comprehend book work, bed ridden for three years, unable to drive, unable to ski, teeth hurt and mouth hurt, my ears ring, my eyes are dry and the issues have ruined my family. " patient reported being hospitalized five times. Symptoms are ongoing. A company healthcare professional notes there is no medical evidence to link the symptoms of sinusitis, feelings of panic, facial tightness, inability to move jaw, mouth clenches, neck tightness, issues affecting heart, sleep disturbances, possible stroke, ¿swoosh in neck and head¿, ringing ears, and dry eyes to the patient¿s filler injection.
Manufacturer Narrative
The events of huge blister, skin and body hurt, and blood coming down throat are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event of blister as follows: adverse events postmarket surveillance "the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. All adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma. ".
Event Description
Patient provided the following additional information: patient also suffers from a huge blister on their face, their skin and body hurt, and they have blood coming down their throat. A company healthcare professional notes there is no medical evidence to link the following additionally reported symptoms to the patient's filler injection: brain damage, unable to walk, hair is knotted up, feels like they have lost their life, heart rate is low, heart rate raises with anxiety, issues with nostrils and drainage, has hard crusty things in the nose, black bloody things in the nose, mouth is like a desert, teeth are rough, weight loss, unable to eat, the juvéderm® has gone up into the brain, has a cold with sneezing and water and black stuff coming out of the nose like they have a permanent cold, and their eyes have no water in them. The patient stated that they have been prescribed antibiotics. The patient stated that when they see physicians about the symptoms the physicians don¿t believe them.
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Manufacturer (Section D)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
MDR Report Key6273921
MDR Text Key65624457
Report Number3005113652-2017-00034
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM-CONC/ADD
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2017 Patient Sequence Number: 1