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Catalog Number 94640
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)
Event Date 03/08/2018
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The event of "allergic reaction" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. A review of the device history record has been completed. No deviations or non-conformances noted. 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. 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
Patient called and reported that they were injected with 1 syringe of juvéderm voluma® xc underneath the cheekbone and around the eyes and immediately the patient had a very bad reaction. Their heart rate increased, and they felt like that had the flu with diarrhea and vomiting. The patients¿ face was very swollen, their whole face had blue discoloration, they couldn't smile because their face was so big. The patients¿ vision is getting really bad and has gone from 1. 25 to 2. 25 prescription, things are blurry in front of them, and they cant see things in front of their face. The patient also reported that they feel a tingling sensation in their face, throat, neck, chest, and arms. The patient stated that they look like a puffer fish and they have anxiety and are panicking. They have a hard time sleeping. The patient went to the hospital and they prescribed pepcid, zyrtec, benadryl, and prednisone for 5 days to the patient. The patient saw the injector who said to relax and take a loprazolam because they thought the patient was just panicking. The patient requested the filler be taken out with hyaluronidase but the injector told them to wait a month. The patient stated that the injector does not think there are any issues and thinks the patient is making the symptoms up and referred them to a psychiatrist and neurologist because they may have a brain tumor because they keep reporting these symptoms. The symptoms have not resolved. The patient saw a dermatologist who said it could be an allergic reaction. The patient saw an ophthalmologist concerning the vision issues and they felt it was normal aging vision issues and did not think it was due to the filler injection. The patient stated that they have a history of anaphylaxis and that they told the injector prior to injection that they are very allergic to lidocaine and the injector said there was no lidocaine in the filler but the patient was told by another dermatologist that the filler has lidocaine in it. The patient stated that they went back to the injector and asked them about it and the injector said that it did have lidocaine in it. The patient stated that the injector does not believe the patient has an allergy to lidocaine and wants to test them for allergies to lidocaine and every other ingredient in juvéderm voluma® xc. The patient also reported that they had talked prior to the injection with the injector and had agreed the filler would be put in the marionette lines but they did not inject there and when they asked the injector they said they never had said they would inject in the marionette lines. The patient stated that they have allergies and anaphylactic reactions to all ¿clinolin products¿ as well as to lidocaine. The patient has a history of hashimoto¿s disease. The patient was concomitantly taking 50 micrograms of synthroid, has not had prior fillers. The patient was concomitantly injected with botox® in between the brows but does not think the botox® has anything to do with the symptoms. A numbing agent was used prior to the injection.
Event Description
Additional information: patient stated they "feel awful. ".
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Manufacturer (Section D)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
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
MDR Report Key7469797
MDR Text Key106833750
Report Number3005113652-2018-00530
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/15/2019
Device Catalogue Number94640
Device Lot NumberVB20A70718
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial