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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 ¿swelling and tenderness over entire face and all injected sites,¿ "lesion," ¿immunologic reaction/general histamine reaction," and ¿firm¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: 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.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: table 1 and 2: treatment site responses by maximum severity and duration occurring in > 5% of subjects after initial treatment (n = 265).Possible treatment site responses include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.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 a patient was injected with 1 syringe of juvéderm voluma® xc in cheeks and marionettes.28 days later they were injected with 1 syringe of juvéderm volbella® xc in perioral area and with juvéderm® ultra plus in nasolabial folds.Approximately 6 weeks later, the patient was injected with 1 syringe of juvéderm volbella® xc in perioral area as a touch up treatment.The 2 weeks after that, the patient was injected with 1 syringe of juvéderm vollure¿ xc in marionettes and nasolabial folds and with half syringe juvéderm voluma® xc in cheeks.About 3 weeks later, the patient was injected with juvéderm® (unspecified) in temples, and half syringe of juvéderm voluma® xc in cheeks and marionettes.Approximately 4 months later, the patient was injected with 1 syringe juvéderm volbella® xc in lips and with 1 syringe juvéderm voluma® xc in cheeks, nasolabial folds, and marionettes.About 4 months later, the patient received hormone pills and the patient began taking sulfur supplements during this time.The 2 days after taking the hormone pills and sulfur supplements, the patient experienced swelling and tenderness over entire face and all injected sites.Not red, just firm and swollen.Tender from the swelling.No fever.5 days later, healthcare professional advised the patient to stop taking sulfur supplement and to take benadryl and medrol.Symptoms improved, but recurred after stopping treatment.Antibiotics (minocycline) and a steroid (prednisone) taper prescribed at an unknown time.Healthcare professional stopped steroid treatment half way through due to patient reaction to it.Approximately a month later, medrol was prescribed again and 3 vials hylenex were injected.The 6 days later, 2 more vials hylenex were injected.The results presented minimal improvement.The 12 days later, triamcinolone and 5fu injected into patient.Healthcare professional saw improvement.The 3 days later, the patient's swelling returned.At an unspecified time, the patient saw allergist who believes this to be a general histamine reaction unrelated to fillers.The patient was prescribed 2-month course of steroids.This record represents the initial juvéderm voluma® xc in the cheeks and marionettes.This is the same event and the same patient reported under mdr id#s 3005113652-2018-01010 (allergan complaint #(b)(4)), 3005113652-2018-01011 (allergan complaint #(b)(4)), 3005113652-2018-01012 (allergan complaint #(b)(4)), 3005113652-2018-01013 (allergan complaint #(b)(4)), 3005113652-2018-01014 (allergan complaint #(b)(4)), 3005113652-2018-01015 (allergan complaint #(b)(4)), 3005113652-2018-01016 (allergan complaint #(b)(4)), 3005113652-2018-01017 (allergan complaint #(b)(4)), 3005113652-2018-01009 (allergan complaint #(b)(4)).This mdr is being submitted for another suspect product, juvéderm voluma® xc, also a device manufactured by allergan.

• 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: 7786089
• MDR Text Key: 117302740
• Report Number: 3005113652-2018-01018
• Device Sequence Number: 1
• Product Code: LMH
• 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
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 07/25/2018
• 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