MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLBELLA

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

Patient Problems Rash (2033); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)

Event Date 04/16/2018

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 ¿occlusion¿, ¿rash¿, and ¿skin discoloration¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 4. Warnings ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
30 days. Refer to the adverse events section for details. 5. 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 adverse events with use of dermal fillers, including juvéderm volbella® xc. Refer to adverse events section for details. 6. Adverse events table 1 and 2. Injection site responses by severity and duration after initial treatment occurring in > 5% of treated subjects. Possible treatment site responses include: swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching and dryness. C. Postmarket surveillance the following reported adverse events were received from postmarket surveillance on the use of juvéderm volbella® xc for lip augmentation outside the united states and were not observed in the clinical study. These adverse events, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, loss/lack of correction, hematoma, allergic reaction, infection, paresthesia, herpes, migration, angioedema, and necrosis. In many cases the symptoms resolved without any treatment. Reported treatments included the use of (in alphabetical order): analgesics, antibiotics, antihistamines, anti-viral, arnica, drainage, hyaluronidase, ice, laser treatment, massage, nsaids, steroids, and warm compress. Outcomes for these reported events ranged from resolved to ongoing at the time of last contact.

Event Description

Healthcare professional reported that they injected a patient with juvéderm voluma® xc and juvéderm volbella® xc in the lips and the patient developed an occlusion 3 days after injection. The injector used hyaluronidase to dissolve and the patient got a rash and some discoloration. No other information was provided. This record represents the juvéderm volbella® xc. This is the same event and the same patient reported under mdr id# 3005113652-2018-00602 ((b)(4)). This mdr is being submitted for the second suspect product, juvéderm® ultra xc, also a device manufactured by allergan.

• Brand Name: UNK VOLBELLA
• 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: 7524609
• MDR Text Key: 108608903
• Report Number: 3005113652-2018-00603
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK VOLBELLA
• 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: 04/20/2018
• 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 Treatment Data

Date Received: 05/17/2018 Patient Sequence Number: 1