MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

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.

• Brand Name: JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)
• Type of Device: IMPLANT, 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 Key: 6852656
• MDR Text Key: 85439720
• Report Number: 3005113652-2017-00992
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• 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 Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK JUVEDERM-CONC/ADD
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/15/2017
• 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