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

Catalog Number 95834

Device Problem Particulates (1451)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device analysis summary: visual analysis of the device indicates white particles are observed in the gel next to the tip.Device labeling: 1.Device description juvéderm volbella® xc injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant.It consists of cross-linked hyaluronic acid (ha) produced by streptococcus species of bacteria, formulated to a concentration of 15 mg/ml and 0.3% w/w lidocaine in a physiologic buffer.5.Precautions ¿ juvéderm volbella® xc injectable gel is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.¿ juvéderm volbella® 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; notify allergan product support at 1-877-345-5372.

Event Description

Healthcare professional reported to an allergan representative reports one syringe of juvéderm volbella® xc had "impurities in it." problem noted prior to use of device.No patient contact or injury to patient or staff reported.

• Brand Name: VOLBELLA 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: 7290512
• MDR Text Key: 100905386
• Report Number: 3005113652-2018-00174
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• 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