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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96181
Device Problem Migration (4003)
Patient Problems Inflammation (1932); Skin Irritation (2076)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events of "migrated in to the mucosa and granuloma" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event. 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 to have injected a patient in the vermillion border and superficial lip lines with juvéderm® volbella® xc. Three months later, "it was migrated to the mucosa". Device migration occurred at injection site ¿but deeper, into mucosa" and inflammatory nodule/"granuloma" occurred in the mucosa. The patient was treated with antibiotics and seems to be getting better. Treatment of hyaluronidase injections were provided on 3 occasions. The symptoms have not resolved.
 
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Brand NameJUVEDERM VOLBELLA XC 2 X 1ML 32G
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 Key8421022
MDR Text Key138804591
Report Number3005113652-2019-00224
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
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/15/2019
Device Catalogue Number96181
Device Lot NumberV15LA70817
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 Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2017
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: 03/14/2019 Patient Sequence Number: 1
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