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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLBELLA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)
Event Date 04/16/2018
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 ¿occlusion¿, ¿rash¿, and ¿skin discoloration¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 4. 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. 5. Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. ¿ patients may experience late onset adverse events with use of dermal fillers, including juvéderm volbella® xc. Refer to adverse events section for details. 6. Adverse events table 1 and 2. Injection site responses by severity and duration after initial treatment occurring in > 5% of treated subjects. Possible treatment site responses include: swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching and dryness. C. 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. In many cases the symptoms resolved without any treatment. Reported treatments included the use of (in alphabetical order): analgesics, antibiotics, antihistamines, anti-viral, arnica, drainage, hyaluronidase, ice, laser treatment, massage, nsaids, steroids, and warm compress. Outcomes for these reported events ranged from resolved to ongoing at the time of last contact.
 
Event Description
Healthcare professional reported that they injected a patient with juvéderm voluma® xc and juvéderm volbella® xc in the lips and the patient developed an occlusion 3 days after injection. The injector used hyaluronidase to dissolve and the patient got a rash and some discoloration. No other information was provided. This record represents the juvéderm volbella® xc. This is the same event and the same patient reported under mdr id# 3005113652-2018-00602 ((b)(4)). This mdr is being submitted for the second suspect product, juvéderm® ultra xc, also a device manufactured by allergan.
 
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Brand NameUNK VOLBELLA
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 Key7524609
MDR Text Key108608903
Report Number3005113652-2018-00603
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 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLBELLA
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 Received04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/17/2018 Patient Sequence Number: 1
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