• 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 (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) 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 (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM-CONC/ADD
Device Problem Incomplete or Missing Packaging (2312)
Patient Problems Skin Irritation (2076); Complaint, Ill-Defined (2331)
Event Type  Injury  
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 ¿bumps on the lips and unevenness¿ 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: intended use/indications: juvéderm® ultra 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). Juvéderm® ultra xc is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21. Precautions: juvéderm® ultra xc is packaged for single-patient use. Do not resterilize. Do not use if package is opened or damaged. Juvéderm® ultra xc is to be used as supplied. Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity, and performance of the product and it can therefore no longer be assured. Adverse events: the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising. 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. Instructions for use: 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. How supplied: juvéderm® ultra xc injectable gel is supplied in individual treatment syringes with 30 g needles for single-patient use and ready for injection (implantation). The volume in each syringe is as stated on the syringe label and on the carton. The contents of the syringe are sterile and non-pyrogenic. Do not resterilize. Do not use if package is opened or damaged.
 
Event Description
Patient called and reported that they had heard of other patients had complained of "bumps on the lips and unevenness" and that the box did not say "juvéderm®" on it. No indication of treatment. Event resolution is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)
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 Key6852656
MDR Text Key85439720
Report Number3005113652-2017-00992
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
0 Patients were 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 Catalogue NumberUNK JUVEDERM-CONC/ADD
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
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

-
-