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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 96183
Device Problem Migration (4003)
Patient Problems Herpes (1898); Skin Irritation (2076); Vascular System (Circulation), Impaired (2572)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events of ¿device has migrated lateral, turned white, palpable nodule, red mottled skin, hsv, and superior labial artery occlusion" 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 deviations or non-conformances are found, a supplemental medwatch will be submitted. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported the day of injection in the lips with one syringe of juvéderm volbella® xc, the patient experienced, ¿the device has migrated lateral near the cheek area, and they are having a hard time dissolving product. ¿ the injector also reported at last injection of lips, "upper right area under nose turned white, and right superior labial artery occlusion. " the next day, there was a "palpable nodule in the right cheek about 1. 5 cm lateral to right angle of mouth and red mottled skin. " treatment began the same day as injection including hylenex, aspirin, heat compresses, and massage to area. The patient had (b)(6) by day #4. Symptoms are ongoing.
 
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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 Key8222221
MDR Text Key132229470
Report Number3005113652-2018-01890
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
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/02/2020
Device Catalogue Number96183
Device Lot NumberV15LA80469
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 Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2018
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: 01/07/2019 Patient Sequence Number: 1
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