• 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 (VOLUME/ADDITIVE UNKNOWN) 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 (VOLUME/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Skin Discoloration (2074)
Event Date 01/04/2019
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of mottled appearance, necrosis and subconjunctival hemorrhage are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported injecting a patient with unspecified juvéderm voluma in the midface and juvéderm volbella with lidocaine in the tear trough. Prior to the injection, the patient was prepped with antiseptic. The day after the injection, the patient developed a mottled appearance at the injection sites. No intervention was given which led to necrosis. Patient has residual healing on the malar and submalar part of the face. Subconjunctival hemorrhage was also seen. Patient was treated with oral and topical antibiotics. Symptoms are ongoing. This is the same event and the same patient reported under mdr id #3005113652-2019-00077 (allergan complaint # (b)(4)). This is the first mdr submitted for the first suspected product, unspecified juvéderm voluma.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN)
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
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key8298869
MDR Text Key134866568
Report Number3005113652-2019-00076
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P110033
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 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM VOLUMA-ADDITIVE
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 Received01/10/2019
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: 02/01/2019 Patient Sequence Number: 1
-
-