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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Unspecified Infection (1930); Skin Inflammation (2443)
Event Date 09/03/2017
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 ¿swelling on the left cheek," ¿white blisters," and ¿a tooth infection¿ 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 ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks. Refer to the adverse events section for details. 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 per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n
=
265), possible treatment site responses post injection with juvéderm voluma® xc include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Treatment site responses reported by [less than or equal to] 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. Device- and injection related adverse events occurring in [less than or equal to] 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%). Postmarket surveillance juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013. The following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea. Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery. Vision abnormalities have been reported following injection of juvéderm voluma®, with and without lidocaine, into the nose, glabella, periorbital area, and/or cheek, with a time to onset ranging from immediate to 1 week following injection. Reported treatments include anticoagulants, sympathomimetics, steroids, and surgery. Outcomes ranged from resolved to ongoing at the time of last contact. Events requiring medical intervention, and events where resolution information is not available, were reported after injection of juvéderm voluma® with and without lidocaine in the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use (see warnings section). ".
 
Event Description
Healthcare professional reported after injection under the eyes and in the cheeks with 3 syringes of juvéderm voluma® xc, the patient began experiencing ¿swelling on the left cheek," ¿white blisters," and ¿a tooth infection¿ 3 days later. Patient was provided amoxicillin by a dentist, however the injector changed the prescription to ¿keflex & a medrol dosepak¿ on the same day. Symptoms are ongoing, but resolving.
 
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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 Key6902935
MDR Text Key87726263
Report Number3005113652-2017-01180
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 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/08/2018
Device Catalogue Number94640
Device Lot NumberVB20A70308
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 Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2017
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: 09/28/2017 Patient Sequence Number: 1
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