• 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 94151EC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Edema (1820); Hypersensitivity/Allergic reaction (1907)
Event Date 12/10/2016
Event Type  Injury  
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. The events of allergic reaction, erythema, edema, ecchymosis, are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported events as follows: undesirable effects "the patient must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include but are not limited to: inflammatory reactions (redness, oedema, erythema, etc), which can occur simultaneously with itching or pain on pressure, can appear after the injection. These reactions can last for a week. Haematomas. Cases of necroses in the glabellar region, abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have been reported. It is therefore advisable to take these potential risks into account. ".
 
Event Description
Healthcare professional reported patient was injected to the glabellar fold and low nasolabial fold with juvéderm voluma with lidocaine. Approximately 2 months later patient developed an allergic reaction with erythema at the application areas. Physician additionally notes patient developed "[illegible] edema reaction at glabellar and [illegible] nasal. Ecchymosis [illegible]. Product + edema were palpated. " patient experienced "swelling that started with an edema on the front, and increases in the eye region and [illegible] nose. There is a [illegible] on the left internal corner [illegible]. Patient reported no fillers procedure recently. Patient is also experiencing allergy in [illegible]. " patient was treated with allegra, hyaluronidase, intralesional tramginolona and an illegible treatment. Symptoms are ongoing.
 
Manufacturer Narrative
Device history record summary: the release step combined with the absence of any deviation shows that that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications. The extrusion force value shows an expected consistency of the product. The sterilization cycle is registered as conforming.
 
Event Description
Healthcare professional reported patient was injected to the glabellar fold and low nasolabial fold with juvéderm¿ voluma¿ with lidocaine. Approximately 2 months later patient developed an allergic reaction with erythema at the application areas. Physician additionally notes patient developed "[illegible] edema reaction at glabellar and [illegible] nasal. Ecchymosis [illegible]. Product + edema were palpated. " patient experienced "swelling that started with an edema on the front, and increases in the eye region and [illegible] nose. There is a [illegible] on the left internal corner [illegible]. Patient reported no fillers procedure recently. Patient is also experiencing allergy in [illegible]. " patient was treated with allegra, hyaluronidase, intralesional tramginolona and an illegible treatment. Symptoms are ongoing.
 
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 Key6228347
MDR Text Key64030564
Report Number3005113652-2016-01011
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCS
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,Followup
Report Date 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Catalogue Number94151EC
Device Lot NumberVB20A50568
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 Received01/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2015
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: 01/06/2017 Patient Sequence Number: 1
-
-