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

Catalog Number 95834

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

Patient Problems Granuloma (1876); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 03/06/2018

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 nodules, swelling, pain, and granuloma dermatitis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event(s) as follows: 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. Precautions ¿ patients may experience late onset adverse events with use of dermal fillers, including juvéderm volbella® xc. Refer to adverse events section for details. Adverse events per tables 1 and 2. Injection site responses by severity and duration after initial treatment occurring in > 5% of treated subjects, possible injection site responses post injection with juvéderm volbella® xc include swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness. 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.

Event Description

Healthcare professional reported a patient was injected with 1 syringe of juvéderm volbella® xc around the lips and above the right brow, the patient had a delayed response 6 months after injection with the patient experiencing nodules, swelling, and pain around the lips, above the right brow, and in the lip area and went to an emergency room at a hospital. Later the healthcare professional saw the patient and performed a biopsy which came back with granuloma dermatitis and mixed dermal inflammation associated with dermal filler. The physician dissolved the area with hyaluronidase, treated the patient with intralesional kenalog, and applied warm compresses. Healthcare professional stated they have seen a positive change but do not know if the symptoms have resolved.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: 7385927
• Report Number: 3005113652-2018-00374
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/08/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70074
• 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: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention