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

Catalog Number 94728ED

Device Problem Shelf Life Exceeded (1567)

Patient Problems Edema (1820); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reporter has declined to provide allergan further information regarding event, product, or patient details.The events of infection, pimple, swelled and went hard 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 documentary research in the batch file 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 for the reported events of edema, skin irritation, skin inflammation, infection and shelf-life exceeded: "contra-indications: juvéderm® volbella® with lidocaine must not be used in areas presenting cutaneous inflammatory and/or infectious processes (acne, herpes, etc.).Precautions for use: as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials should be followed.Undesirable effects: the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching, and/or pain on pressure and/or paraesthesia, occurring after the injection.These reactions may last for a week.In particular, it has to be noted that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of these tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.Induration or nodules at the injection site.Warnings: check the expiry date on the product label.Juvéderm® volbella® with lidocaine gel must be used prior to the expiration date printed on the package.".

Event Description

Healthcare professional reported injecting a patient with juvéderm® volbella® with lidocaine in the perioral and forehead as well as juvéderm® voluma® with lidocaine in the cheeks (no complaint with this injection).About 3 months later, the patient had their perioral area and forehead "flare up." the symptoms started as "a pimple on left side of the mouth and then swelled and then spread to right side - went hard." a biopsy was done by the patient's general practitioner and the results "showed nothing." patient was then put on antibiotics and the symptoms settled 2 weeks later.The healthcare professional was informed of the event about 2 weeks after symptoms first appeared and believes it was an "introduced infection." the injection with juvéderm® volbella® with lidocaine was injected 5 days after expiration.

• 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: 6581488
• MDR Text Key: 75631284
• Report Number: 3005113652-2017-00370
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 94728ED
• Device Lot Number: V15LA40157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA® WITH LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR