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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95661
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Skin Inflammation (2443)
Event Date 09/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Further information from the reporter regarding event, product, or patient details will be requested. No additional information is available at this time. The events of allergic reaction, swelling, itching, blisters, area is broken out, redness, lopsided, deformed, and "looks like a chemical burn" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 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. 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 vollure¿ xc. Refer to adverse events section for details. Adverse events: per table 1: injection site responses by maximum severity in > 5% of subjects after initial treatment, possible injection site responses post injection with juvéderm vollure¿ xc include: firmness, swelling, tenderness to touch, lumps/bumps, redness, pain after injection, bruising, itching, and discoloration. The following aes were received from postmarket surveillance on the use of juvéderm vollure¿ xc outside the united states and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. These aes, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, skin nodule, loss/lack of correction, hematoma, allergic reaction, necrosis, infection, flu-like symptoms, paresthesia, migration of device, abscess, drainage, herpes, malaise, headache, and anxiety. In addition, 1 report of blurry vision after injection in the periorbital area, 1 report of blurry vision after injection in an unspecified area, and 1 report of stroke after injections in an unspecified area with multiple dermal fillers were reported. Three adverse events at the juvéderm vollure¿ xc nlfs occurred weeks to months after the injection procedure. These events included mild swelling, moderate skin mass, and severe itching. Swelling was treated with fexofenadine hydrochloride and ibuprofen, the skin mass was treated with triamcinolone, and the itching did not require any treatment. All 3 events resolved without sequelae.
 
Event Description
Patient reported that the day after injection in the marionette lines and smile lines with juvéderm vollure¿ xc they experienced ¿a severe allergic reaction, thick raised swelling around the chin, mouth and nose, throat itching, blisters, areas is broken out, redness, look lopsided, looks deformed and the area looks like a chemical burn. ¿ patient was treated with an ¿oral steroid¿ and also went to the emergency room where they received "iv medications for an allergic reaction, a steroid shot, benadryl and pepsid. " event resolution is unknown at this time.
 
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Brand NameJUVEDERM VOLLURE XC 2X1 ML
Type of DeviceIMPLANT, 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 Key6946525
MDR Text Key89348842
Report Number3005113652-2017-01190
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/12/2019
Device Catalogue Number95661
Device Lot NumberV17LA70223
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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