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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Edema (1820); Staphylococcus Aureus (2058); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
The events of purple lips and vessels that might be compromised by swelling 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(s) as follows: "4. Warnings: the product must not be injected into blood vessels. Introduction of juvéderm® ultra xc 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soft-tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary.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 professional specialist should an intravascular injection occur (see health care professional instructions #13). B. Health care professional instructions: 13. If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color. Blanching may represent a vessel occlusion. If normal skin coloring does not return, do not continue with the injection. Treat in accordance with american society for dermatologic surgery guidelines, which include hyaluronidase injection. 7. The injection technique for wrinkles, folds, and lips may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered. A linear threading technique, serial puncture injections, fanning technique, crosshatching technique, or a combination have been used to achieve optimal results. Injecting the product too superficially may result in visible lumps and/or discoloration. ".
Event Description
Additional information: lipstick was applied right after injection. The patient also claimed to have a "horrible reaction" in their lips, they became purple and "almost exploded. " an attempt was made to start the patient on antibiotics, antiviral and medication to dilate small vessels that might be compromised by the swelling. The patient also went to the emergency room where they were instructed to take the antibiotics. A culture was also taken. "the infection was limited to one anatomical area even though same syringe injections were performed in more than one area. ".
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of "immediate swelling," bruising, and "staph infection" 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(s) as follows: "warnings: ¿ injection site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
7 days in facial wrinkles and folds, and typically last
14 days in the lips. Refer to the adverse events section for details. Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. Adverse events: ¿ the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising. Clinical evaluation of juvéderm® ultra xc for lip augmentation in the clinical study, 11 severe treatment-related adverse events occurred in 4 subjects. These adverse events include angioedema and injection site mass, pain, bruising, swelling, erythema, and hypertrophy. All of these events resolved without sequelae, and all except the angioedema required no action. One subject experienced angioedema in the upper lip following topical anesthetic application of 25% lidocaine/7% tetracaine and injection of juvéderm® ultra xc, which resolved following administration of oral antihistamine, hyaluronidase injection, and oral anti-inflammatory medication. 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. In many cases, the symptoms resolved without any treatment. Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress. ".
Event Description
Patient reported they were injected in the "lips, cheeks, and under the eyes" with 2 syringes of juvéderm® ultra xc. The patient reported they experienced "immediate swelling in the lips and cheeks, and bruising under the eyes. " the patient also reported that they have developed "a staph infection" 2 days after injection, but the location was not specified. Patient has been provided antibiotics and nitroglycerin 2 days after injection. The symptoms "have cleared up mostly, but there is still some swelling. ".
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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 Key6373257
MDR Text Key117730638
Report Number3005113652-2017-00132
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2017
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: 03/02/2017 Patient Sequence Number: 1