MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154EC

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Separation (1562)

Patient Problem Burning Sensation (2146)

Event Type  malfunction  

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 "burning" 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 addresses the reported event(s) as follows: "method of use-posology ¿ remove tip cap by pulling it straight off the syringe as shown in fig.1.Then firmly push the needle provided in the box (fig.2) into the syringe, screwing it gently clockwise.Twist once more until it is fully locked and has the needle cap in the position shown in fig.3.If the needle cap is positioned as shown in fig.4, it is incorrectly attached.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig.5, and pulling the two hands in opposite directions.Inject slowly.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level.".

Event Description

Company representative reported on behalf of the healthcare professional who noted during injection with 1 syringe of juvéderm ultra¿ xc, the patient complained about ¿burning.¿ healthcare professional realized that the product was not coming out of the syringe, and the burning was due to the injection of air into the patient's face.Healthcare professional ¿pressed the plunger a little stronger for the product to come out, then the syringe burst, leaking product into the patient's face.¿ symptom of ¿burning¿ resolved and no longer occurred with use of another syringe.

Event Description

Healthcare professional elaborated that the luer lock system broken during the application into the nasogenian fold using the "retro injection" technique, which resulted in loss of product, air inside the syringe, and impossibility to complete the procedure.Packaged needle was used.

Manufacturer Narrative

Device analysis: 1 empty syringe of 1.0ml received in an opened tray without cap but with one needle which still attached.No defect observed.

Event Description

Company representative reported on behalf of the healthcare professional who noted during injection with 1 syringe of juvéderm ultra¿ xc, the patient complained about ¿burning.¿ healthcare professional realized that the product was not coming out of the syringe, and the burning was due to the injection of air into the patient's face.Healthcare professional ¿pressed the plunger a little stronger for the product to come out, then the syringe burst, leaking product into the patient's face.¿ symptom of ¿burning¿ resolved and no longer occurred with use of another syringe.

• Brand Name: JUVEDERM ULTRA XC 1 ML ROW
• 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: 6996669
• MDR Text Key: 91951935
• Report Number: 3005113652-2017-01405
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA60398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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
• Patient Outcome(s): Other