• 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 (VOLUME/CONCENTRATION/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 (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK JUVEDERM-CONC/ADD
Device Problem Migration (4003)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. Clarification: "infection", and "migration" are known potential adverse events addressed in the product labeling.
 
Event Description
Healthcare professional reports a mid-face lift and moderate postoperative contour deformity. Patient was treated with injection of an unspecified juvéderm® product in the mid face. An unspecified amount of time later, unspecified juvéderm® and juvéderm voluma® xc were injected into the midface. The patient experienced ¿product migration, thinning of the skin, increasing contour deformities at areas adjacent to the injections. ¿ incision and drainage completed at least 7 times as treatment. The symptoms are ongoing. Permanent damage probable and noted as ¿skin discoloration, seromas, lack of attachment of skin to soft tissues. ¿ per healthcare professional, "not only was this deforming psychologically devastating, but [patient] still cannot show face in public. " this is the same event and the same patient reported under mdr id# 3005113652-2020-00464 (allergan complaint #(b)(4)) and mdr id# 3005113652-2020-00466 (allergan complaint #(b)(4)). This mdr is being submitted for the second injection with an unspecified juvéderm® product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM (VOLUME/CONCENTRATION/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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key10356486
MDR Text Key201377096
Report Number3005113652-2020-00465
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK JUVEDERM-CONC/ADD
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 Received07/08/2020
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: 08/03/2020 Patient Sequence Number: 1
Treatment
JUVÉDERM VOLUMA® XC
-
-