• 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 94151ED
Device Problems Detachment Of Device Component (1104); Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling: method of use-posology juvéderm® voluma® with lidocaine is to be used as supplied. Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured. Remove tip cap by pulling it straight off the syringe as shown in fig. 1. Then firmly push the needle provided in the box (fig. 2) into the syringe, screwing it gently clockwise. Twist once more until it is fully locked and has the needle cap in the position shown in fig. 3. If the needle cap is positioned as shown in fig. 4, it is incorrectly attached. Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig. 5, and pulling the two hands in opposite directions. Prior to injecting, depress the plunger rod until the product flows out of the needle. Inject slowly and apply the least amount of pressure necessary. If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle. Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.
 
Event Description
Healthcare professional reported having a syringe of juvéderm voluma with lidocaine that were difficult to extrude and the needle popped off. During the injection, the product extruded onto the patient's skin and the syringe disconnected. The remaining product was extremely difficult to inject. The product did not flow normally, did not have the same consistency. The product had a much thick consistency, and was difficult to get in. There were no injuries. Packaged needle was used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM VOLUMA WITH LIDOCAINE 1ML
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 Key7603724
MDR Text Key111894117
Report Number3005113652-2018-00682
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeAS
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number94151ED
Device Lot NumberVB20A70689
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 Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
-
-