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); Inflammation (1932); Skin Inflammation (2443)

Event Date 11/02/2017

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 hot, allergic reaction, swollen, welts, blisters, and cold sore are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: contraindications; juvéderm voluma® xc is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies. 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. Adverse events per table 1: treatment site response 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. 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. Postmarket surveillance: 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. Health care professional instructions: 18. Patients may experience treatment site responses, which typically resolve within 2 to 4 weeks. Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.

Event Description

Patient reported they were injected with unspecified juvéderm® and juvéderm voluma® xc. Patient was injected in the lips, cheeks and nasolabial folds but was unsure of where each product was injected. After injection patient stated ¿my face immediately got really hot, i feel like i'm having an allergic reaction, my upper lip is swollen, top of my mouth is swollen and has welts, i have blisters over the top lip and the symptoms started after i developed a cold sore on my chin. ¿ symptoms started the same day as the injection and progressed over time. Patient went to the emergency room three times and while there they were treated with an iv of pepcid, an iv of steroids, and were given two steroid shots. Patient was also prescribed oral steroids as well but decided not to take them because they are allergic to steroids. Patient stated they informed the emergency room of their allergy to steroids but was still given the iv and shots of steroids. Symptoms are ongoing. This is the same event and the same patient reported under mdr id# 3005113652-2017-01619 (allergan complaint #(b)(4)). This mdr is being submitted for the second 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: 7106207
• MDR Text Key: 94479255
• Report Number: 3005113652-2017-01620
• 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: consumer
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/15/2017
• 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

Patient Treatment Data

Date Received: 12/11/2017 Patient Sequence Number: 1