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

Catalog Number 94640

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 04/21/2017

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 infected sebaceous cyst, hard lump and nodules are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling for the reported events of formation of cyst(s), infection and skin irritation: "warnings ¿ product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.Adverse events a.Clinical evaluation of juvéderm voluma® xc 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%).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.".

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma® xc and juvéderm® ultra plus xc in the left and right malar regions as well as nasolabial folds.Three months later, the patient had another injection with juvéderm voluma® xc in the malar region and nasolabial folds.About 5 months later, the patient developed an "infected sebaceous cyst" on the left side of the face both below and at the injection site.Patient was reviewed by their dermatologist and who prescribed antibiotics for the patient 3 days later.Patient then later developed a "hard lump/nodule" in the left cheek which was treated with hyaluronidase by the healthcare professional.A week after that, the patient developed a lump on the right cheek and another lump was found in the nasolabial folds a week later.Patient was again treated with hyaluronidase each time.The nodules/lumps were unresponsive to the hyaluronidase treatments.There was no drainage or inflammation present.Patient was also treated with novocain multiple times.The symptoms are improving.This is the same event and the same patient reported under mdr id #3005113652-2017-00596 ((b)(4)) and mdr id #3005113652-2017-00597 ((b)(4)).This is the first mdr submitted for the first suspected product, the second injection with juvéderm voluma® xc.

• 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: 6671570
• MDR Text Key: 78544567
• Report Number: 3005113652-2017-00506
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A60326(11)160817(17)180117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2018
• Device Catalogue Number: 94640
• Device Lot Number: VB20A60326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR