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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94201JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 12/02/2021
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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. 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.
 
Event Description
Healthcare professional (hcp) reported patient was injected with juvéderm® volift¿ and approximately 15 months later again with another injection of juvéderm® volift¿. Patient experienced "oedema total face and nodular induration of the cheeks became bilateral" approximately 17 months after the 2nd injection of juvéderm® volift¿; a few weeks after vaccination against covid-19. Biopsy performed and "confirm the existence of a foreign body granuloma, multiplied by immune stimulation. " patient was treated with cortancyl and methotrexate injection once per week for 3 months. Event is ongoing. This is the same event and the same patient reported under mdr id # 3005113652-2022-00035 (allergan complaint # (b)(4)). This mdr is being submitted for the first injection of juvéderm® volift¿.
 
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Brand NameVOLIFT WITH LIDOCAINE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key13359556
MDR Text Key284913941
Report Number3005113652-2022-00036
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number94201JR
Device Lot NumberV17LA80568
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/26/2022 Patient Sequence Number: 1
Treatment
"ILLEGIBLE"
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