• 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 ULTRA/24HV (VOLUME 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 ULTRA/24HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM ULTRA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
Healthcare reported a patient was injected with 0. 4ml of juvéderm® ultra to the upper lip. "no observed discoloration during the treatment, but the patient noticed a color change" when they "got home in the upper lip area. " hcp received photos 4-days post-treatment, which appeared of blisters and patient expressed severe pain and pressure. Hcp administered 9 vials of hyal that same day which resolved the issue. Hcp suspects accidental placement of filler in the superior labial artery. ".
 
Manufacturer Narrative
Age at the time of event: mid 30's. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. 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. This is a known potential adverse event addressed in the product labeling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM ULTRA/24HV (VOLUME UNKNOWN)
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 Key13696022
MDR Text Key286992987
Report Number3005113652-2022-00138
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK JUVEDERM ULTRA
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2022
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 Unkown

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
-
-