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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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation (2443)
Event Date 09/15/2017
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 contact dermatitis, allergic reaction, itching, tenderness, swelling, and a rash 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. Adverse events: per table 1 and table 2: injection site responses by maximum severity and duration after initial treatment occurring in > 5% of treated subjects (n
=
123) for 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. Per table 3, injection site responses by severity and duration after repeat treatment with juvéderm vollure® xc occurring in > 5% of treated subjects (n
=
91) include firmness, swelling, tenderness to touch, redness, lumps/bumps, pain after injection, bruising, itching, and discoloration. Aes after initial/touch-up treatment occurring in
=
5% of nlfs included injection site bruising, erythema, pain, discoloration, pruritus, reaction, and facial asymmetry. In general, aes at the nlfs were mild or moderate in severity for both products, with 49. 1% (27/55) mild and 29. 1% (16/55) moderate for juvéderm vollure¿ xc. Some aes at the nlfs were severe (21. 8%, 12/55). The majority of the aes at the nlfs required no action to be taken (94. 5%, 52/55) and resolved without sequelae (98. 2%, 54/55). Aes at the nlfs after initial/touch-up treatment that required treatment included swelling treated with antihistamines and nsaids, injection site erythema treated with antibiotics, and skin mass that was biopsied and treated with steroids. One subject had mild injection site swelling that occurred after initial/touch-up treatment and was ongoing at the end of the study. This ae did not require treatment. 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. All asymmetry corrections (if needed) and repeat treatments were performed with juvéderm vollure¿ xc. In general, aes at the nlfs after asymmetry correction/repeat treatment were similar to those after initial/touch-up treatment. Within the juvéderm vollure¿ xc randomization group, after asymmetry correction/repeat treatment, 20 aes were reported in 10. 8% (10/93) of nlfs, with the most common ae being injection site induration (firmness) in 7. 5% (7/93) of nlfs. All other aes occurred in < 5% of nlfs and included injection site mass, pain, bruising, erythema, discoloration, and swelling. A majority of the aes after asymmetry correction/repeat treatment in nlfs originally treated with juvéderm vollure¿ xc were mild (20. 0%, 4/20) or moderate (45. 0%, 9/20) in severity, required no action to be taken (100%, 20/20), and resolved without sequelae (65. 0%, 13/20). Some aes after asymmetry correction/repeat treatment were severe (35. 0%, 7/20). After asymmetry correction/ repeat treatment, seven aes were ongoing at the end of the study and included injection site induration, mass, swelling, bruising, and discoloration. These aes did not require treatment. ".
 
Event Description
Healthcare professional reported the day of injection in the marionette lines, nasolabial, & perioral with 1 syringe of juvéderm vollure¿ xc, the patient experienced contact dermatitis, allergic reaction, itching, tenderness, swelling, and a rash, at the injection sites. Patient was treated with a medrol dosepak and valtrex the next day. The symptoms resolved within two weeks of injection.
 
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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 Key6947118
MDR Text Key89356084
Report Number3005113652-2017-01194
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received10/13/2017
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
Is the Reporter a Health Professional? Yes
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 Initial

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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