MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAÏNE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151II

Device Problems Material Too Rigid or Stiff (1544); Expulsion (2933)

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

Event Date 10/06/2017

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 material rigid or stiff and expuslion: "5.Precautions ¿ juvéderm voluma® xc injectable gel is a clear, colorless gel without visible particulates.In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe ¿ failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.10.Shelf life and storage store at room temperature (up to 25°c/77°f).Do not freeze.Juvéderm voluma® xc injectable gel has a clear appearance.In the event that a syringe contains material that is not clear, do not use the syringe;".

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine using the packaged needle.During the injection, healthcare professional had found crystals in the syringe.An attempt was made to remove the crystals, but resulted in the product being wasted.There were no injuries.The syringe was stored as advised.The device was examined by allergan representatives and found an "air bubble present towards the plunger and no crystals observed.".

Manufacturer Narrative

Visual analysis of the returned device noted an empty syringe was received with a cap.No defect was found.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine using the packaged needle.During the injection, healthcare professional had found crystals in the syringe.An attempt was made to remove the crystals, but resulted in the product being wasted.There were no injuries.The syringe was stored as advised.The device was examined by allergan representatives and found an "air bubble present towards the plunger and no crystals observed.".

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAÏNE
• 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: 6973424
• MDR Text Key: 90763031
• Report Number: 3005113652-2017-01296
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 94151II
• Device Lot Number: VB20A60391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• 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
• Patient Age: 30 YR