MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problem Migration (4003)

Patient Problem Skin Irritation (2076)

Event Date 08/23/2018

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 a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek" and induration are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device labeling: precautions: patients may experience late onset nodules with use ofdermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.Adverse events: device/injection-related adverse events occurring in = 1% of subjects included injection site hypertrophy (0.7%), nodule (0.7%), inflammation (0.4%), injection site anesthesia (0.4%), injection site dryness (0.4%), injection site erosion (0.4%), mass (0.4%), contusion (0.4%) and syncope (0.4%).Treatment site responses reported by = 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness.Two subjects (0.7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device.Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye.The subject also experienced nodularity in the right cheek approximately 7 months after treatment.The second subject experienced lumps in the cheeks approximately 7 months after treatment.A couple of days before the onset, the subject experienced myofascial pain and body aches.Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase.All events resolved.Among the 167 subjects who received repeat treatment, 8.4% (14/167) experienced a device/injection-related aes following treatment.All aes after repeat treatment occurred within 1 month of repeat treatment.The rate of device/injection-related aes was lower after repeat treatment compared to initial/touch-up treatment.The most common aes were injection site mass and induration (table 6).Instructions for use: the injection technique for juvéderm voluma® xc with regard to the angle and orientation of the bevel, the depth (subcutaneous and/or submuscular/supraperiosteal) of injection, and the quantity administered may vary depending on the area being treated.Injection of juvéderm voluma® xc too superficially (intradermally), or in large volumes over a small area, may result in visible and persistent lumps and/or discoloration.Juvéderm voluma® xc should be distributed in small aliquots (small boluses of 0.1 ml to 0.2 ml) over a large area to reduce the risk of persistent lumpiness.

Event Description

Healthcare professional called to report a patient was injected with juvéderm voluma® xc in the cheeks and juvéderm vollure¿ xc in the nasolabial folds in seven months ago.The patient additionally received restylane in last year in the nasolabial folds.The patient presented to the office today with a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek." hcp indicated it is one big nodule the size of a golf ball that has gotten bigger (closer to a baseball).The patient was treated with hylenex.No other information provided.This record will be in reference to injection with juvéderm voluma® xc.Symptoms remain ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2018-01349 (allergan complaint # (b)(4)).This mdr is being submitted for juvéderm voluma® xc (lot vb20a80162).

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• 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: 7991302
• MDR Text Key: 124567956
• Report Number: 3005113652-2018-01348
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM VOLLURE¿ XC IN THE NASOLABIAL FOLDS
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR