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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVÉDERM VISTA ULTRA PLUS JAPAN IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVÉDERM VISTA ULTRA PLUS JAPAN IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 93857JA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Embolism (1829); Skin Inflammation (2443)
Event Date 03/27/2018
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 pustule, redness, swelling and embolization are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling for the reported event of impaired vascular system circulation and skin inflammation: [warnings] 1. *do not inject into blood vessels. [it may cause occlusion of blood vessels, embolization, ischemia, or infarction. ] 2. *use the product with caution when injecting into the regions where the skin is typically thin and there is less collateral circulation (such as inferior to the orbital rim, the tear trough, periorbital area (eg, crow¿s feet lines), glabellar and forehead. ). [temporary and permanent vision abnormalities/blindness, leading to stroke (cerebral ischemia, cerebral hemorrhage, cerebral infarction), necrosis (of nasal alar etc. ) and damage to underlying facial structures may be caused by mis-injection into blood vessels or compression etc. Of blood vessels and nerves. ] use shall be based on a thorough understanding of the facial anatomy of the injection area. Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel (such as changes in vision, signs of a stroke, blanching of the skin, or unusual pain) during or shortly after the procedure. Also, since the rheology value for this product is higher (harder) than that for juvedermvista ultra, and its risk of compression of blood vessels and/or nerves is higher, caution must be exercised for injection into periorbital area (eg, crow¿s feet lines), glabellar and forehead with an option of switching to juvéderm vista ultra. 3. Malfunctions and adverse events (2) adverse events nodule, beading, granuloma, allergic reaction/hypersensitivity, herpes, loss/lack of correction, migration of the product/displacement, necrosis (caused by embolization and compression of blood vessels etc. ), numbness/paresthesia, pain, abscess, infection, angioedema, discoloration/coloration, haematoma/ecchymosis, itching, inflammatory reaction, redness/rash, swelling/oedema, others (autoimmune disease, dizziness, deeper wrinkle/scar, dry skin, dyspnea, flu-like symptoms, headache, malaise, myasthenia, nausea, scar, symptoms of autoimmune/connective tissue disorders, syncope, vasospasm, vision abnormalities etc. ).
 
Event Description
Healthcare professional reported injecting a patient with juvéderm vista ultra plus in the nasolabial fold. Patient was also injected with botox on the forehead and glabella. On the next day, the patient developed a pustule on the right side of the nasolabial fold and had swelling and redness on the forehead, nose and right side of the nasolabial fold. Healthcare professional suspected embolization. Patient received treatment with hyaluronidase 2 days after onset. Patient had follow up with another clinic and currently has no confirmation of an ulcer and the redness is recovering.
 
Event Description
Additional information: symptoms developed the same day of the injection. Two months after the injection, the patient was reviewed at another clinic and the patient is recovering. Patient still has a small sized redness on the right nasolabial fold. The forehead and nose had redness when blood circulation is increased. Treatment for the acute phase of the symptoms have been completed.
 
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Brand NameJUVÉDERM VISTA ULTRA PLUS JAPAN
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 Key7469867
MDR Text Key106833747
Report Number3005113652-2018-00433
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P050047
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 06/11/2018
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 Catalogue Number93857JA
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 Received05/14/2018
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

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