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

Catalog Number 93857JA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 06/10/2018

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 embolization is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device labeling: [warnings]: usage method: 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 infraction), necrosis (of nasal alar etc.) and damage to underlying facial structures may be caused by mis-injection into blood vessels or compress etc.Of blood vessels and nerves.] use shall be based on 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 juvéderm vista 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.

Event Description

Healthcare professional reported injecting a patient with juvéderm vista ultra plus.Two days later, the patient developed embolization and was treated with hyaluronidase.Symptoms have resolved.

• Brand Name: JUVÉDERM VISTA ULTRA PLUS JAPAN
• Type of Device: IMPLANT, 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 Key: 7645403
• MDR Text Key: 112571524
• Report Number: 3005113652-2018-00836
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 93857JA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• 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: Initial
• Patient Sequence Number: 1