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 Ecchymosis (1818); Edema (1820); Skin Discoloration (2074)

Event Date 01/28/2016

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 bruising, permanent discoloration, and swelling are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications. The extrusion force value shows an expected consistency of the product. The sterilization cycle is registered as conforming. Device labeling addresses the reported event(s) as follows: "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. Adverse events per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n
=
265) 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 [less than or equal to] 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. Device- and injection related adverse events occurring in [less than or equal to] 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%). 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. Vision abnormalities have been reported following injection of juvéderm voluma®, with and without lidocaine, into the nose, glabella, periorbital area, and/or cheek, with a time to onset ranging from immediate to 1 week following injection. Reported treatments include anticoagulants, sympathomimetics, steroids, and surgery. Outcomes ranged from resolved to ongoing at the time of last contact. Events requiring medical intervention, and events where resolution information is not available, were reported after injection of juvéderm voluma® with and without lidocaine in the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use (see warnings section). ".

Event Description

Healthcare professional reported that approximately 1 month after injection in the lateral and medial malar areas, all below the areas, and v2-v3 areas with two syringes of juvéderm voluma® xc (lot# vb20a50193) the patient was experiencing bruising, discoloration, and swelling at the injection sites. The "initial bruising and swelling resolved. " the patient was "deemed to need more volume. " approximately 2 months after the initial injection, the patient was injected in the v-3 area with 1 cc of juvéderm voluma® xc (lot# vb20a50224). No bruising occurred, but the patient began developing edema over the next few months. The patient was treated with a medrol dosepak approximately 7 months after the initial symptom presentation. All of the initially reported symptoms are reported as ongoing. Patient was taking armour thyroid and valerian concomitantly with injection. Further follow up from the injector revealed the following: approximately 9 months after symptom presentation the patient still has some discoloration. The swelling has resolved. Further follow up from the injector was received. The following information was noted: the patient was injected with vitrase. The patient felt that the vitrase ¿did some good. The right side looks fine however the left side is sunken. ¿ ¿both eyes are still quite dark underneath, but not as bad as before. ¿ ¿the cases have resolved, however the patient is still experiencing some permanent discoloration. The swelling has resolved but only did so by removing some of the voluma using vitrase, and recreating the tear trough. ¿ this is the same event and the same patient reported under mdr id# 3005113652-2017-00105 (allergan complaint #1348605). This is the first mdr submitted for the first suspect product, the first injection with juvéderm voluma® xc (lot# vb20a50193).

• 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: 6373460
• MDR Text Key: 68849309
• Report Number: 3005113652-2017-00104
• 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: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/28/2016
• Device Catalogue Number: 94640
• Device Lot Number: VB20A50193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/02/2017 Patient Sequence Number: 1

Treatment

ARMOUR THYROID, VALERIAN