MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94506KO

Device Problems Crack (1135); Shelf Life Exceeded (1567)

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

Event Date 09/29/2017

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.Device labeling: 1.Device description juvéderm voluma® xc is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant.It consists of crosslinked hyaluronic acid (ha) produced by streptococcus species of bacteria, formulated to a concentration of 20 mg/ml and 0.3% w/w lidocaine in a physiologic buffer.5.Precautions ¿ juvéderm voluma® xc 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.¿ 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.B.Health care professional instructions 6.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.10.Shelf life and storage juvéderm voluma® xc injectable gel must be used prior to the expiration date printed on the label.Store at room temperature (up to 25°c/77°f).Do not freeze.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the chin using the packaged needle.While changing the needle, the luer lock cracked and bubble was formed.There was no impact to the patient or staff.

Manufacturer Narrative

Visual analysis of the returned device noted the 1.0ml syringe contained 0.55ml of gel remaining in the syringe with a crack observed on the 3mm luer lock level and a bubble outside of specification found at the luer lock level.The device had also exceeded expiration date.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the chin using the packaged needle.Initial use of the syringe.While changing the needle, the luer lock cracked and bubble was formed.There was no impact to the patient or staff.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1 ML
• 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: 6985605
• MDR Text Key: 91224636
• Report Number: 3005113652-2017-01327
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 94506KO
• Device Lot Number: VB20A30210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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: 41 YR