MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94703RX

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event(s) as follows: "method of use - posology ¿ juvéderm® volift¿ with lidocaine is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.".

Event Description

Healthcare professional reported to a company representative that they ¿couldn¿t put the cannula 25g on the syringe correctly¿ with 1 syringe of juvéderm® volift¿ with lidocaine.Product was ¿wasted¿ and ¿leaked on the side.¿ problem location was noted to be at the ¿damaged¿ luer lock.Event ¿did not occur when a needle was used.¿ healthcare professional tried again with another cannula, but the problem remained the same.There was a loss of 0.2ml of product.Patient contact was made in the nasogenian fold.Injection in the ¿nasojugal fold¿ was not performed due to the ¿damaged¿ luer lock.There were no injuries to the patient.

Manufacturer Narrative

Device analysis: 1.0 ml syringe with 0.3 ml of gel remaining in it received with a cap, 1 unused needle, 1 used cannula in an opened volift tray.No defect observed to syringe.

Event Description

Healthcare professional reported to a company representative that they ¿couldn¿t put the cannula 25g on the syringe correctly¿ with 1 syringe of juvéderm® volift¿ with lidocaine.Product was ¿wasted¿ and ¿leaked on the side.¿ problem location was noted to be at the ¿damaged¿ luer lock.Event ¿did not occur when a needle was used.¿ healthcare professional tried again with another cannula, but the problem remained the same.There was a loss of 0.2ml of product.Patient contact was made in the nasogenian fold.Injection in the ¿nasojugal fold¿ was not performed due to the ¿damaged¿ luer lock.There were no injuries to the patient.

• Brand Name: VOLIFT WITH LIDOCAINE
• 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: 7141130
• MDR Text Key: 95798083
• Report Number: 3005113652-2017-01715
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• 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
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA60328
• 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: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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
• Patient Age: 59 YR