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 Inflammation (1932); Skin Irritation (2076); Discomfort (2330)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).In response to fda report number mw5072181.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.The events of ¿large cheek granulomas¿ and ¿discomfort and disfigurement¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.Device labeling: 4.Warnings ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks.Refer to the adverse events section for details.5.Precautions.¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Refer to adverse events section for details.6.Adverse events a.Clinical evaluation of juvéderm voluma® xc per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment, possible treatment site responses post injection with juvéderm voluma® xc include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration and itching.Postmarket surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013.The following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.

Event Description

Healthcare professional reported approximately 10-11 months after injection with 1ml of juvéderm voluma® xc patient developed large cheek granulomas.The events were identified on ct scan and the patient experienced discomfort and disfigurement.Patient was initially prescribed antibiotics and was additionally injected with hyaluronidase in each cheek.Symptoms are ongoing.

• 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: 6987764
• MDR Text Key: 90579406
• Report Number: 3005113652-2017-01270
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A60230(11)160527(17)171027
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2017
• Device Catalogue Number: 94640
• Device Lot Number: VB20A60230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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