• 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 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 IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96637JR
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. 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 (hcp) reported patient injected with 1ml of juvéderm® voluma¿ with lidocaine in the zygomatic bone. Patient received dental treatment almost a month later. Approximately after three months post injection, patient presented with "massive swelling [on the] cranial left cheek [and] oozng of the implant. " treatment was noted as amoxicillin / clavulanic and prednisolone. Symptoms resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM VOLUMA WITH LIDOCAINE
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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key12094400
MDR Text Key266164135
Report Number3005113652-2021-03075
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeGM
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number96637JR
Device Lot NumberVB20B00477
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 Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/30/2021 Patient Sequence Number: 1
-
-