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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95661
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 11/23/2021
Event Type  Injury  
Event Description
Healthcare professional reported the patient was injected with 3 ml of juvéderm® voluma¿ xc into midface (2. 2 ml right side and 0. 8 ml left side) and 1 ml of juvéderm® vollure¿ xc into smile lines. Two months later, patient experienced multiple painful, dense, and hard nodules around cheek and mouth that look like one big nodule increase of volume. Biopsy showed "foreign giant cell reaction. " patient was injected with hyaluronidase. A week later, patient was treated with keflex, prednisone with doxycycline. A month later, patient was treated again with prednisone and doxycycline. Symptoms has not been resolved. This is the same event and the same patient reported under mdr id # 3005113652-2022-00025 (allergan complaint # (b)(4)). This mdr is being submitted for the suspect product, juvéderm® vollure¿ xc.
 
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.
 
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Brand NameJUVEDERM VOLLURE XC 2X1 ML
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 Key13518564
MDR Text Key286023262
Report Number3005113652-2022-00083
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/07/2022
Device Catalogue Number95661
Device Lot NumberV17LB00408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2020
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: 02/11/2022 Patient Sequence Number: 1
Treatment
JUVÉDERM® VOLUMA¿ XC
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