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 Inflammation (1932); Peeling (1999); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 05/31/2018

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 "patient complained of their right nose and right eye running with no pain and a bubbling blister above the lip" 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: 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: 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.Instructions for use: patients may have mild to moderate injection site responses after treatment in the lips and perioral area, which typically resolve within 14 days.Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.The health care professional should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of juvéderm volbella® xc.

Event Description

Health professional reported that a patient complained of their right nose and right eye running with no pain and a bubbling blister above the lip after they were injected with juvéderm volbella® xc.Treatment is noted as nitropaste, 400 units of hyaluronidase, warm compresses, mupirocin, and cutagenix.It was noted that the patient had ¿dental work (b)(6) 2018 impressions taken.¿ events are ongoing at this time.

Event Description

Health professional also reported that the patient "developed a lot of inflammation and early flaking of skin which was treated with cutagenix.¿ events have resolved.

Manufacturer Narrative

The events of "a lot of inflammation and early flaking of skin" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• 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
• MDR Report Key: 7643285
• MDR Text Key: 112548089
• Report Number: 3005113652-2018-00824
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• 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
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA80021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR