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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 94728JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 09/16/2021
Event Type  Injury  
Event Description
Healthcare professional reported injecting a patient with 0. 8 ml of juvéderm® volbella¿ with lidocaine in the tear trough and eye bag area. A year and a half later, the patient developed a lump in the cheek, cellulitis on the right side of the face with "malar formation to be studied" and had inflammation in the eye bag area. A biopsy was performed of the lump and confirmed a granulomatoses reaction. The patient was treated with doflazocoir. The event is ongoing.
 
Manufacturer Narrative
(b)(4). The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event of "granuloma" is a physiological complication 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 new, changed or corrected information is noted, a supplemental medwatch will be submitted. This is a known potential adverse event addressed in the product labeling.
 
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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
MDR Report Key12611729
MDR Text Key281922800
Report Number3005113652-2021-03309
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number94728JR
Device Lot NumberV15LA90333
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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