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

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE

  • 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
 

ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95661
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Discoloration (2074); Urticaria (2278); Skin Inflammation (2443)
Event Date 08/14/2017
Event Type  Injury  
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 delayed swelling, blanching, pain, contact dermatitis, and urticarial response 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 ¿ immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of stroke, blanching of the skin, or unusual pain during or shortly after the procedure. ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
30 days. Refer to the adverse events section for details. Precautions ¿ patients may experience late-onset adverse events with use of dermal fillers, including juvéderm vollure¿ xc. Refer to adverse events section for details. Adverse events per table 1 and table 2: injection site responses by maximum severity and duration after initial treatment occurring in > 5% of treated subjects (n
=
123) for possible injection site responses post injection with juvéderm vollure® xc include firmness, swelling, tenderness to touch, lumps/bumps, redness, pain after injection, bruising, itching, and discoloration. Per table 3, injection site responses by severity and duration after repeat treatment with juvéderm vollure® xc occurring in > 5% of treated subjects (n
=
91) include firmness, swelling, tenderness to touch, redness, lumps/bumps, pain after injection, bruising, itching, and discoloration. Aes after initial/touch-up treatment occurring in
=
5% of nlfs included injection site bruising, erythema, pain, discoloration, pruritus, reaction, and facial asymmetry. Postmarket surveillance 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. Health care professional instructions 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. 1 (see warnings section. ).
 
Event Description
Healthcare professional reported after injection in the perioral region with 1 syringe of juvéderm vollure¿ xc, the patient developed "delayed swelling and blanching of the skin" at the injection sites approximately 6 weeks later. Healthcare professional is treating the symptoms as "contact dermatitis. " it was noted patient experienced an urticarial response as well; pain was also reported, but not at the injection site. Patient was provided an antihistamine and a topical steroid shortly after symptoms appeared. It was noted the treatments have not helped and symptoms are ongoing. The patient takes triamterene and potassium concomitantly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM VOLLURE XC 2X1 ML
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
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
7372473605
MDR Report Key6853576
MDR Text Key85574710
Report Number3005113652-2017-01046
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/13/2019
Device Catalogue Number95661
Device Lot NumberV17LA70224
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 Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2017
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: 09/08/2017 Patient Sequence Number: 1
-
-