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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96637RX
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 06/18/2020
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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: 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 reports patient injection with juvéderm® voluma¿ with lidocaine in the nasogenian groove.Product was injected in a facial artery.Immediately after the injection, patient experienced "an occlusion of the artery, even reaching the lesion to the forehead." event caused "whitening and then the violet coloration of the path of the facial artery." the patient treated with hyaluronidase and hospitalized.The patient evolved positively and "is fine, fully recovered.".
 
Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
 
Event Description
Healthcare professional reports patient injection with juvéderm® voluma¿ with lidocaine in the nasogenian groove.Product was injected in a facial artery.Immediately after the injection, patient experienced "an occlusion of the artery, even reaching the lesion to the forehead." event caused "whitening and then the violet coloration of the path of the facial artery." the patient treated with hyaluronidase and hospitalized.The patient evolved positively and "is fine, fully recovered.".
 
Manufacturer Narrative
Additional data: b.5., d.6.
 
Event Description
Hyaluronidase was applied immediately after injection.Symptoms resolved 2 weeks later.
 
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Brand Name
JUVEDERM VOLUMA WITH LIDOCAINE
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR  74370
MDR Report Key10289255
MDR Text Key199265285
Report Number3005113652-2020-00398
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,Followup,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Catalogue Number96637RX
Device Lot NumberVB20A90733
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received07/17/2020
Supplement Dates Manufacturer Received07/28/2020
08/27/2020
Supplement Dates FDA Received08/24/2020
09/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age51 YR
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