MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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

Patient Problems Inflammation (1932); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding the event, product, or patient details has been requested.No additional information is available at this time.The events of ¿allergic reaction, ¿bumps/pimples¿, and ¿red and irritated¿ 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 events as follows: contraindications: ¿ juvéderm vollure¿ xc injectable gel is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.¿ juvéderm vollure¿ xc contains trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.¿ juvéderm vollure¿ xc contains lidocaine and is contraindicated for patients with a history of allergies to such material.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.Precautions: ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.Adverse events: ¿the majority of isrs were mild or moderate and resolved within 3 days (table 5).One device/procedure-related ae was observed after repeat treatment.The subject experienced redness around the mouth, swelling, and lower sensibility requiring treatment with corticoid ointment; the ae symptoms resolved in 51 days.Health care professional instructions: ¿the injection technique may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered.Different techniques such as serial puncture, tunneling, fanning, cross-hatching or a combination has been used to achieve optimal results.Injecting the product too superficially may result in visible lumps and/or discoloration.Patient instructions: ¿ within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages.Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites.

Event Description

Company representative reported on behalf of healthcare professional that one day after injection in the mid cheek, on either side, with one syringe of juvéderm vollure¿ xc and in the smile lines, on either side, with half of one syringe of juvéderm® ultra plus xc, the patient showed signs of an allergic reaction.Symptoms progressed over the following days.The patient experienced bumps and pimples all over the face and it was red and irritated.Symptoms were not limited to the injection sites.A treatment with a topical numbing creating was administered pre-injection and a topical antibiotic was given post-injection.Healthcare professional is unsure if the symptoms are related to the product or to the topical creams.Further follow-up with the healthcare professional revealed that the patient¿s symptoms occurred in the ¿low face¿ and the signs of an allergic reaction, redness, and irritation occurred at the injection site.¿blt topical¿ numbing cream was given as a pre-treatment and ¿triple antibiotic cream¿ was given as post-injection treatment.Additional treatment with antihistamine, ¿chlorpheniramine,¿ oral steroid, ¿prednisone 40 mg/day,¿ and topical steroid, ¿lidex topical¿ were provided to the patient four days after the injection.Symptoms resolved 6 days afterwards.This is the same event and the same patient reported under mfr #3005113652-2017-00875.This is the first mdr submitted for the second suspected product, juvéderm vollure¿ xc.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 6828054
• MDR Text Key: 83903423
• Report Number: 3005113652-2017-00885
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)V17LA70171(11)170313(17)190213
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: 95661
• Device Lot Number: V17LA70171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ¿BLT TOPICAL¿, JUVÉDERM® ULTRA PLUS XC
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR