• 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 XC 27G 2 X 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 XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94640
Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Local Reaction (2035)
Event Type  Injury  
Manufacturer Narrative
Additional information: evaluation codes.
 
Event Description
Company representative reported that a patient was "reacting" 10 days post injection with juvéderm voluma® xc. It was noted that it looked like a reaction at first and then developed into abscess eventually. It was also noted that there was a possibility of "product being contaminated. " treatment was noted as doxycycline, ¿prednisone doxy, ¿prednisone taper¿, ¿hyaluronidase¿, ¿septra/[illegible], ¿fail aspiration¿, ¿labs 11/22 more hylanex 3cc [illegible] cheek to cx, [illegible], added clinda¿, ¿admitted to shme cx sent, r cheek puss aspirated, l cheek, ct max, drainable fluid zoysn +vanco wbc 17. 6 cx- ngtd, clinically got worse in hospital- id [illegible]¿, ¿surgical ied in or, 4 vials of tylenol used too¿, ¿i&d/hyaluronidase. ¿ total of 6 vials of hyaluronidase used. Event is ongoing at this time. Event lead to "lid retraction. ".
 
Manufacturer Narrative
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. 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 ¿reacting¿ and ¿abscess¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: contraindications: ¿ juvéderm voluma® xc is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies. ¿ juvéderm voluma® xc contains trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material. ¿ juvéderm voluma® xc contains lidocaine and is contraindicated for patients with a history of allergies to such material. Precautions: ¿ health care professionals are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications. Warnings: ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks. Refer to the adverse events section for details. Adverse events: ¿the following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea. Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.
 
Event Description
Company representative reported that a patient was "reacting" 10 days post injection with juvéderm voluma® xc. It was noted that it looked like a reaction at first and then developed into abscess eventually. Treatment was noted as doxycycline, ¿prednisone doxy, ¿prednisone taper¿, ¿hyaluronidase¿, ¿septra/[illegible], ¿fail aspiration¿, ¿labs 11/22 more hylanex 3 cc [illegible] cheek to cx, [illegible], added clinda¿, ¿admitted to shme cx sent, r cheek puss aspirated, l cheek, ct max, drainable fluid zoysn +vanco wbc 17. 6 cx- ngtd, clinically got worse in hospital- id [illegible]¿, ¿surgical ied in operating room (or), 4 vials of tylenol used too¿, ¿i and d/hyaluronidase. ¿ total of 6 vials of hyaluronidase used. Event is ongoing at this time. Event lead to "lid retraction. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM VOLUMA XC 27G 2 X 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 Key7167322
MDR Text Key229300653
Report Number3005113652-2017-01676
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/20/2018
Device Catalogue Number94640
Device Lot NumberVB20A70471
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2017
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: 01/05/2018 Patient Sequence Number: 1
-
-