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

Catalog Number 94703RX

Device Problems Fracture (1260); Expulsion (2933)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling for the reported event of fracture and expulsion: "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.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.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 injecting a patient with juvéderm® volift¿ with lidocaine in the nasogenian using the packaged needle.During injection, it was "notice that there was no effect on the skin, when removing the device the product was on the face of the patient." it was noted that the syringe "presents a fracture in the thread which caused the filtration" and when "placing the needle a click that did not give importance because it could not see any problem." there was "structural defect" in the "nozzle." there was no patient impact.The injection was completed with another syringe.

• 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: 6833671
• MDR Text Key: 85618214
• Report Number: 3005113652-2017-00944
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA60439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• 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: 33 YR