MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

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

Patient Problems Cyst(s) (1800); Inflammation (1932); Skin Irritation (2076)

Event Date 10/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The events of tender, erythematous, hard nodules, cyst or polyp, and inflammatory changes are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: 4.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.¿ 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 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.C.Other safety data 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 patient was injected in the nasolabial folds and marionettes with 1ml of juvéderm voluma® xc in another clinic.Approximately 3.5 months later patient developed tender, erythematous, hard nodules.After symptoms began patient was treated by the injecting clinic with two rounds of keflex and hyaluronidase.After treatment, the patient was still not happy with the results and saw the reporting physician who administered hylenex and biaxin.Patient¿s symptoms are 80% improved.Further follow-up with the treating physician revealed that the patient was injected with another 1 ml of juvéderm voluma® xc 5 days after the initial injection.Symptoms developed approximately 3 months after injection and were located at the injection sites.It was reported that the ¿hard nodules improved almost immediately after hylenex to the area.¿ two ct scans of the patient¿s face were performed one week after treatment.The first was performed without contrast to evaluate inflammatory changes and to determine if an abscess is present.A follow up ct scan with contrast was given the following day which indicated a ¿stable area of increased attenuation along nasal labial folds¿ and ¿retention cyst or polyp present within the right maxillary antrum.¿ results stated that the ¿increased attenuation along the nasal labial folds suggesting cosmetic injections¿ which ¿inflammatory changes can have similar imaging appearances on ct.¿ healthcare professional plans to inject more hylenex to the nasolabial nodules and marionette area.This is the same event and the same patient reported under mdr id# 3005113652-2017-01584 ((b)(4)).This is the first mdr submitted for the first suspect product, the first injection of juvéderm voluma® xc.

Manufacturer Narrative

Additional data: describe event or problem.

Event Description

Additional information: healthcare professional later reported that an additional treatment with hylenex was given to address ¿nodules left nasolabial fold, and very small nodule in the right marionette line¿ after patient ¿finished two weeks of biaxin.¿ one week later, patient reported ¿nodules have resolved and no new symptoms are present.¿.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME 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: 7081514
• MDR Text Key: 93682894
• Report Number: 3005113652-2017-01583
• Device Sequence Number: 1
• Product Code: LMH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR