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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95834
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Granuloma (1876); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 03/06/2018
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 nodules, swelling, pain, and granuloma dermatitis 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. Precautions ¿ patients may experience late onset adverse events with use of dermal fillers, including juvéderm volbella® xc. Refer to adverse events section for details. Adverse events per tables 1 and 2. Injection site responses by severity and duration after initial treatment occurring in > 5% of treated subjects, possible injection site responses post injection with juvéderm volbella® xc include swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness. Postmarket surveillance the following reported adverse events were received from postmarket surveillance on the use of juvéderm volbella® xc for lip augmentation outside the united states and were not observed in the clinical study. These adverse events, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, loss/lack of correction, hematoma, allergic reaction, infection, paresthesia, herpes, migration, angioedema, and necrosis.
 
Event Description
Healthcare professional reported a patient was injected with 1 syringe of juvéderm volbella® xc around the lips and above the right brow, the patient had a delayed response 6 months after injection with the patient experiencing nodules, swelling, and pain around the lips, above the right brow, and in the lip area and went to an emergency room at a hospital. Later the healthcare professional saw the patient and performed a biopsy which came back with granuloma dermatitis and mixed dermal inflammation associated with dermal filler. The physician dissolved the area with hyaluronidase, treated the patient with intralesional kenalog, and applied warm compresses. Healthcare professional stated they have seen a positive change but do not know if the symptoms have resolved.
 
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Brand NameVOLBELLA WITH LIDOCAINE
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 Key7385927
MDR Text Key103970241
Report Number3005113652-2018-00374
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/08/2019
Device Catalogue Number95834
Device Lot NumberV15LA70074
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 Received03/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2017
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: 03/30/2018 Patient Sequence Number: 1
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