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 Pain (1994); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 01/23/2017

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 "red small pimples, red, induration, tenderness, tenderness, swelling, cluster of pustules, and abscess" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. A review of the device history record has been completed. No deviations or non-conformances noted. Device labeling: 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. Adverse events: two subjects (0. 7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device. Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye. The subject also experienced nodularity in the right cheek approximately 7 months after treatment. The second subject experienced lumps in the cheeks approximately 7 months after treatment. A couple of days before the onset, the subject experienced myofascial pain and body aches. Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase. All events resolved. All device/injection-related aes after repeat treatment were mild to moderate, required no action, and resolved without sequelae. Generally, device/injection-related aes were less severe after repeat treatment compared to initial/touch-up treatment, and most resolved within 3 months. Similar to the initial/touch-up treatment, 3 subjects experienced a device/injection-related ae that lasted more than 180 days, but all resolved without requiring any treatment. Device/injection-related adverse events occurring in
=
1% of subjects included injection site swelling (0. 6%), injection site pain (0. 6%), and injection site papule (0. 6%). 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

Health professional reported that a patient experienced red small pimples, red, induration, tenderness, tenderness, swelling, cluster of pustules, and abscess to right marionette area after they were injected with juvéderm voluma® xc in the cheeks/nlf/marionettes. Treatment is noted as hyaluronidase, clindamycin, cypromycin, cirpofloxacin, vitrase, and incision and drainage. Events have resolved. Patient was concomitantly injected with juvéderm volbella® xc. These are the same events and the same patient reported under mdr id # 3005113652-2018-00862 ((b)(4)). This mdr is being submitted for juvéderm voluma® xc.

• 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: 7703458
• MDR Text Key: 114482284
• Report Number: 3005113652-2018-00861
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/15/2018
• Device Catalogue Number: 94640
• Device Lot Number: VB20A60498
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 07/19/2018 Patient Sequence Number: 1

Treatment

JUVÉDERM VOLBELLA® XC IN THE LIPS