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Catalog Number 95661
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bacterial Infection (1735); Loss of Vision (2139); Anxiety (2328); Skin Inflammation (2443); Blood Loss (2597); Fluid Discharge (2686)
Event Date 03/14/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant therapies: clonazepam. (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 ¿purplish color of the skin, blisters, boils, and the left side of my nose blew up, and i looked like a freak¿, ¿swelling¿, ¿blisters filled with fluids, which started draining and getting bigger¿, ¿touched one blister which looked like a pimple and it burst leaving a mass of skin hanging down, later it left a hole in that area¿, and ¿the patient¿sterilized a needle and drained the bumps of clear fluid and flesh¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: adverse events: in general, aes at the nlfs were mild or moderate in severity for both products, with 49. 1% (27/55) mild and 29. 1% (16/55) moderate for juvéderm vollure¿ xc. Some aes at the nlfs were severe (21. 8%, 12/55). The majority of the aes at the nlfs required no action to be taken (94. 5%, 52/55) and resolved without sequelae (98. 2%, 54/55). Aes at the nlfs after initial/touch-up treatment that required treatment included swelling treated with antihistamines and nsaids, injection site erythema treated with antibiotics, and skin mass that was biopsied and treated with steroids. One subject had mild injection site swelling that occurred after initial/touch-up treatment and was ongoing at the end of the study. This ae did not require treatment. Three adverse events at the juvéderm vollure¿ xc nlfs occurred weeks to months after the injection procedure. These events included mild swelling, moderate skin mass, and severe itching. Swelling was treated with fexofenadine hydrochloride and ibuprofen, the skin mass was treated with triamcinolone, and the itching did not require any treatment. All 3 events resolved without sequelae. All asymmetry corrections (if needed) and repeat treatments were performed with juvéderm vollure¿ xc. In general, aes at the nlfs after asymmetry correction/repeat treatment were similar to those after initial/touch-up treatment. Within the juvéderm vollure¿ xc randomization group, after asymmetry correction/repeat treatment, 20 aes were reported in 10. 8% (10/93) of nlfs, with the most common ae being injection site induration (firmness) in 7. 5% (7/93) of nlfs. All other aes occurred in < 5% of nlfs and included injection site mass, pain, bruising, erythema, discoloration, and swelling. A majority of the aes after asymmetry correction/repeat treatment in nlfs originally treated with juvéderm vollure¿ xc were mild (20. 0%, 4/20) or moderate (45. 0%, 9/20) in severity, required no action to be taken (100%, 20/20), and resolved without sequelae (65. 0%, 13/20). Some aes after asymmetry correction/repeat treatment were severe (35. 0%, 7/20). After asymmetry correction/repeat treatment, seven aes were ongoing at the end of the study and included injection site induration, mass, swelling, bruising, and discoloration. These aes did not require treatment. On the validated recovery early symptoms module of the face-q questionnaire, the majority of subjects reported feeling not at all or only a little bothered by all 17 symptoms 3 days after initial treatment with juvéderm vollure¿ xc. Subjects reported less discomfort (9. 9% for juvéderm vollure¿ xc vs 25. 7% for control), tenderness (11. 5% vs 30. 5%), soreness (10. 8% vs 28. 9%), and swelling (15. 1% vs 40. 0%) after treatment with juvéderm vollure¿ xc compared to treatment with the control. For all other symptoms (bruising, tightness, numbness, stinging, burning, throbbing, tingling, itching, tired, feverish, lightheaded, headaches, and pain), subjects reported similar results between juvéderm vollure¿ xc and control. Subjects were monitored throughout the study for any adverse events (aes) by the investigator. Aes that were related to the study device/procedure were recorded. Expected aes, listed in the directions for use (dfu), were only reported as aes if the events were assessed to be more severe or more prolonged than routinely observed. After repeat treatment, subjects completed a 30-day safety diary to record the severity and duration of any injection site responses (isrs). No device/procedure-related ae was observed after the initial/touch-up treatment. Forty-one subjects completed the 30-day safety diary after repeat treatment. The most frequently reported isrs in the diaries were swelling (87. 8%, 36/41), firmness (80. 5%, 33/41), and tenderness to touch (78. 0%, 32/41). The majority of isrs were mild or moderate and resolved within 3 days (table 5). One device/procedure-related ae was observed after repeat treatment. The subject experienced redness around the mouth, swelling, and lower sensibility requiring treatment with corticoid ointment; the ae symptoms resolved in 51 days. Juvéderm vollure¿ xc has been marketed outside the us since 2011 as juvéderm volift® with lidocaine. The following aes were received from postmarket surveillance on the use of juvéderm vollure¿ xc outside the united states and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. These aes, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, skin nodule, loss/lack of correction, hematoma, allergic reaction, necrosis, infection, flu-like symptoms, paresthesia, migration of device, abscess, drainage, herpes, malaise, headache, and anxiety. In addition, 1 report of blurry vision after injection in the periorbital area, 1 report of blurry vision after injection in an unspecified area, and 1 report of stroke after injections in an unspecified area with multiple dermal fillers were reported. In many cases the symptoms resolved without any treatment. Reported treatments for these events included the use of (in alphabetical order): analgesics, anesthetics, antibiotics, anti-allergy medications, antifungal, antihistamines, anti-inflammatory medications, antiviral, arnica, aspiration, drainage, hyaluronidase, ice, massage, nitrates, oral and topical corticosteroids, and warm compress. Outcomes for these reported adverse events ranged from resolved to ongoing at the time of last contact. Instructions for use: with patients who have localized swelling, the degree of correction is sometimes difficult to judge at the time of treatment. In these cases, it is better to invite the patient back to the office for a touch-up treatment. Within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites.
Event Description
Patient reported that after an injection in the ¿cheeks, lips, around the mouth, and in each cheek bone¿ with juvéderm vollure¿ xc, they experienced ¿purplish color of the skin, blisters, boils, and the left side of [their] nose blew up, and [they] looked like a freak,¿. Patient also experienced ¿swelling¿, ¿blisters filled with fluids, which started draining and getting bigger. ¿ patient ¿touched one blister which looked like a pimple and it burst leaving a mass of skin hanging down, later it left a hole in that area. ¿ the patient stated they ¿sterilized a needle and drained the bumps of clear fluid and flesh. ¿ patient was treated with hydrocortisone cream, po, and steroids. Treatment with antibiotics are planned, and filler will also be dissolved. Patient is afraid that their face will look deformed. Symptoms are ongoing. This is the same event and the same patient reported under mdr id 3005113652-2018-01706 ((b)(4)). This mdr is being submitted for juvéderm vollure¿ xc (lot # v17la70739).
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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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
MDR Report Key8116909
MDR Text Key128888330
Report Number3005113652-2018-01613
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2019
Device Catalogue Number95661
Device Lot NumberV17LA70739
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2017
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: 11/29/2018 Patient Sequence Number: 1