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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94640
Device Problem Migration (4003)
Patient Problem Skin Irritation (2076)
Event Date 08/23/2018
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 a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek" and induration 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 initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Device labeling: precautions: patients may experience late onset nodules with use ofdermal fillers, including juvéderm voluma® xc. Refer to adverse events section for details. Adverse events: device/injection-related adverse events occurring in
=
1% of subjects included injection site hypertrophy (0. 7%), nodule (0. 7%), inflammation (0. 4%), injection site anesthesia (0. 4%), injection site dryness (0. 4%), injection site erosion (0. 4%), mass (0. 4%), contusion (0. 4%) and syncope (0. 4%). Treatment site responses reported by
=
5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness. Two subjects (0. 7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device. Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye. The subject also experienced nodularity in the right cheek approximately 7 months after treatment. The second subject experienced lumps in the cheeks approximately 7 months after treatment. A couple of days before the onset, the subject experienced myofascial pain and body aches. Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase. All events resolved. Among the 167 subjects who received repeat treatment, 8. 4% (14/167) experienced a device/injection-related aes following treatment. All aes after repeat treatment occurred within 1 month of repeat treatment. The rate of device/injection-related aes was lower after repeat treatment compared to initial/touch-up treatment. The most common aes were injection site mass and induration (table 6). Instructions for use: the injection technique for juvéderm voluma® xc with regard to the angle and orientation of the bevel, the depth (subcutaneous and/or submuscular/supraperiosteal) of injection, and the quantity administered may vary depending on the area being treated. Injection of juvéderm voluma® xc too superficially (intradermally), or in large volumes over a small area, may result in visible and persistent lumps and/or discoloration. Juvéderm voluma® xc should be distributed in small aliquots (small boluses of 0. 1 ml to 0. 2 ml) over a large area to reduce the risk of persistent lumpiness.
 
Event Description
Healthcare professional called to report a patient was injected with juvéderm voluma® xc in the cheeks and juvéderm vollure¿ xc in the nasolabial folds in seven months ago. The patient additionally received restylane in last year in the nasolabial folds. The patient presented to the office today with a "decent sized nodule that started in the nasolabial folds on the left side of the face and migrated into the whole side of the cheek. " hcp indicated it is one big nodule the size of a golf ball that has gotten bigger (closer to a baseball). The patient was treated with hylenex. No other information provided. This record will be in reference to injection with juvéderm voluma® xc. Symptoms remain ongoing. This is the same event and the same patient reported under mdr id # 3005113652-2018-01349 (allergan complaint # (b)(4)). This mdr is being submitted for juvéderm voluma® xc (lot vb20a80162).
 
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Brand NameJUVEDERM VOLUMA XC 27G 2 X 1ML
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 Key7991302
MDR Text Key124567956
Report Number3005113652-2018-01348
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 company representative,health
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2019
Device Catalogue Number94640
Device Lot NumberVB20A80162
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 Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
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: 10/22/2018 Patient Sequence Number: 1
Treatment
JUVÉDERM VOLLURE¿ XC IN THE NASOLABIAL FOLDS
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