• 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) UNK JUVEDERM VOLUX 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) UNK JUVEDERM VOLUX IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
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 to the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. The event of abscess (not device related) is considered an unexpected adverse drug experience.
 
Event Description
Healthcare professional reported that juvederm volux "is much firmer to touch than voluma in the immediate post procedure period. " "in one patient, volux in their cheek and chin became acutely erythematous the day after treatment a short time after they developed a rash at the posterior hairline. They had pustule in this area on the day of treatment that both them and i were unaware of; they found it that evening and picked it. It resolved within 2 days with cephalexin 500mg bd and a reducing course of prednisone and has not recurred. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK JUVEDERM VOLUX
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key11089419
MDR Text Key224149643
Report Number3005113652-2020-00794
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
-
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/29/2020 Patient Sequence Number: 1
-
-