• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94493ZQ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported that a patient was injected with juvéderm¿ voluma¿ with lidocaine.The patient experienced swelling in the chin where the product was injected.The hcp saw the patient a year later; patient has ¿swelling, redness and hard nodules.¿ the event is ongoing.
 
Event Description
Healthcare professional reported that a patient was injected with 3 ml of juvéderm¿ voluma¿ with lidocaine (1 ml per cheek and 1 ml in the chin).The patient experienced swelling in the middle and left side of the chin, injection site.The hcp saw the patient about a year later; patient had ¿swelling, redness and hard nodules.¿ ¿felt unwell a few days prior [maybe 2-3 days], could have been triggered by a fl[u] like illness¿.¿the main thing is that the unwell feeling ? flu like symptoms preceded the lumps.At which point [patient] came to see [the physician]¿.Patient was started on antibiotics for 10 days on the reported date of onset.The patient did not wish any other interventions or to dissolve the product.Patient was happy with the outcome.The symptoms resolved 3 days later with no further investigation after the antibiotics.
 
Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Clarification to section h6: the filler was injected into the patient and is not accessible for return.The syringe was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JUVEDERM VOLUMA WITH LIDOCAINE 1ML
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 Key11015592
MDR Text Key221737902
Report Number3005113652-2020-00744
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
Report Date 01/12/2021
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? No
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue Number94493ZQ
Device Lot NumberVB20A90057
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received12/16/2020
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
-
-