• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Complaint, Ill-Defined (2331); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)
Event Date 11/16/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: outcomes to adverse event, describe event or problem.
Event Description
Additional information: event led to permanent damage noted as "scarring upper lip/peri nasal region. ".
Manufacturer Narrative
(b)(4). 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 "vascular compromise and blanching", ¿pain¿, ¿mottled nasal dorsum and central forehead¿, ¿ulcers/vesicles intraorally¿, ¿firm nodule/inflammation¿, ¿dusky area 2-3 mm in glabella¿, ¿oral mucosa edematous blisters¿, ¿ischemia¿, and ¿scar¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: intended use/indications: ¿juvéderm® ultra plus xc injectable gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Warnings: ¿ the product must not be injected into blood vessels. Introduction of juvéderm® ultra plus 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soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary.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 practitioner specialist should an intravascular injection occur (see health care professional instructions #11). ¿ injection procedure reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
7 days¿ duration. Refer to the adverse events section for details. Precautions: ¿ the safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds (eg, lips) have not been established in controlled clinical studies. ¿ the safety in patients with known susceptibility to keloid formation, hypertrophic scarring and pigmentation disorders has not been studied. Clinical studies: ¿a prospective, double-blind, randomized, within-subject, controlled, multicenter clinical study was conducted to evaluate the safety and effectiveness of juvéderm® ultra plus xc compared with juvéderm® ultra plus without lidocaine. The purpose of this study was to evaluate the level of procedural pain (pain during injection) experienced by subjects when treated with each product. The duration of the study was 2 weeks. ¿a total of 36 subjects received a single treatment with juvéderm® ultra plus xc in one nlf and juvéderm® ultra plus without lidocaine in the other nlf. Within 30 minutes after both nlfs were treated, the subjects rated procedural pain on an 11-point scale and a 5-point comparative scale. Both the investigators and subjects rated nlf severity at baseline and 2 weeks after treatment using the 5-point nlf severity scale from the pivotal study. Subjects utilized an interactive voice-response-system diary to record common treatment site reactions for 14 days. ¿the pain scores for the nlfs treated with juvéderm® ultra plus xc were significantly lower (p < 0. 0001) than for the nlfs treated with juvéderm® ultra plus without lidocaine (table 10) based on the 11-point scale. On the comparative scale, 92% (33/36) of subjects rated the side with lidocaine as less or slightly less painful compared to the side without lidocaine (table 11). ¿additionally there have been reports of nodules, infection, and inflammation. ¿ the onset of nodules generally varied from immediate to 2 months post injection. The treatment prescribed included nsaids, antibiotics, steroids, and hyaluronidase. In most cases nodules resolved within 1 month. ¿ the onset of inflammation generally varied from the day of treatment to 1 day post injection. The treatment prescribed included antibiotics, steroids, and needle aspiration. Resolution of symptoms has been reported within 4 days. Adverse events: ¿a 2-week, randomized, controlled us clinical study for juvéderm® ultra xc and ultra plus xc compared with juvéderm® ultra and ultra plus without lidocaine showed a similar safety profile in all subjects (n
72), with the exception of fewer reports of pain/tenderness with the product containing lidocaine. Common treatment site responses (ctr) by severity and duration, are presented in tables 1 and 2. Aside from injection site responses, there were no adverse events related to the device, procedure, or anesthesia. ¿the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, which were not observed in the clinical trials; this includes reports received globally from all sources including scientific journals and voluntary reports. All adverse events obtained through postmarket surveillance with a frequency of 5 or more events are listed in order of prevalence: lack or loss of correction, inflammatory reaction at the injection site, skin rash, bleeding at the injection site, allergic reaction, infection at the injection site, migration, paresthesia, vascular occlusion, necrosis at the injection site, abscess at the injection site, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma. ¿vascular occlusion of vessels resulting in necrosis and vision abnormalities have been reported following injection of juvéderm® products, with and without lidocaine, with a time to onset ranging from immediate to within 1 week following injection. These reported events likely resulted from inadvertent arterial injection. In many of these cases, the product was injected into the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use (see warnings section). Reported treatments include: anticoagulants, epinephrine, aspirin, hyaluronidase, steroid treatment, eye drops, hyperbaric oxygen, and surgery. Outcomes have ranged from completely resolved to ongoing at the time of last contact. ¿inflammatory reaction at the injection site, mostly a nonserious event, has been reported in association with edema, erythema, ecchymosis, pruritus, induration, pain, nodule, blister, abscess, and infection. Time to onset ranged from 1 day to 4 months post juvéderm® ultra plus injection, and outcome ranged from resolved to ongoing at last contact. Interventions prescribed by the health care professionals included topical steroidal cream, oral steroids, and antibiotics. Additional treatment noted was a needle aspiration for drainage of an abscess. ¿serious adverse events have infrequently been reported for juvéderm® ultra plus (reported with a frequency of 5 or more). The most commonly reported serious adverse events were edema, erythema, ecchymosis, and pain. ¿ the most common injection site responses for juvéderm® ultra plus xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising. Instructions for use: ¿if immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color. ¿the injection technique 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, or a combination of the 2 have been used to achieve optimal results. Injecting the product too superficially may result in visible lumps and/or discoloration.
Event Description
Company representative reported on behalf of healthcare professional that following injection with one syringe of juvéderm® ultra plus, the patient experienced vascular compromise and blanching. That day, the patient was treated with hyaluronidase, nitro paste and a warm compress. The patient was fine upon leaving the office. When healthcare professional contacted the patient the next day, the patient reporting being fine. Further follow-up with the healthcare professional revealed that the patient¿s symptoms are ongoing. The day following injection, treatment with a medrol dose pack, valtrex, and aspirin were given and ¿warm compress- patient with pain. ¿ the next day, the patient had pain in the upper, left lip and a ¿mottled nasal dorsum and central forehead. ¿ ¿ulcers/vesicles intraorally¿ were present in the patient¿s left upper lip and patient developed a ¿firm nodule/inflammation¿ in the left nasolabial fold. That day, dilaudid was given as treatment for pain. Mouthwash and hyaluronidase were additionally given as treatment. Two days later, patient¿s pain and bruising had improved. A new onset of a, ¿dusky area 2-3 mm in glabella¿ was present. ¿oral mucosa edematous blisters¿ were also present with ¿no signs of necrosis. ¿ six days after that, patient developed a small, full, thick line above vermillion of left, upper lip. Healthcare professional reported that ¿columella de epithelized but no necrosis intranasal, no blisters¿ and the ischemia was resolving. Pain was still present in the patient¿s cheek and upper lip. Treatment with dilaudid, aspirin, valtrex, advil, silver, and vaseline was continued. Four days following, ¿patient¿s skin is healing with no new areas of concern. Capillary refill is good throughout. Presence of small scar above left lip. Patient is in good spirits. Pain persists in the lip and nose. ¿ patient has a history of previous fillers.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7150916
MDR Text Key229300572
Report Number3005113652-2017-01563
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
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

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1