MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94506JR

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 09/04/2017

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: 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.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.How supplied: juvéderm voluma® xc injectable gel is supplied in individual treatment syringes with needles as indicated on the carton.Juvéderm voluma® xc can be injected with either a 27g ½" or a 25g 1" needle.The volume in each syringe is as stated on the syringe label and on the carton.The contents of the syringe are sterile and non-pyrogenic.Do not resterilize.Do not use if package is open or damaged.Shelf life and storage: 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 in the right temple using the packaged needle.Initial use of the syringe.During the injection, the healthcare professional saw "a crystallized from of hyaluronic acid inside the syringe." the healthcare professional then stopped the injection and removed the device from the patient.Injection was completed with another syringe.Patient is fine with no adverse event.

Manufacturer Narrative

Lab analysis of the device found no defect.

Event Description

Healthcare professional reported injecting a patient with juvéderm® voluma¿ with lidocaine in the right temple using the packaged needle.Initial use of the syringe.During the injection, the healthcare professional saw "a crystallized from of hyaluronic acid inside the syringe." the healthcare professional then stopped the injection and removed the device from the patient.Injection was completed with another syringe.Patient is fine with no adverse event.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1
• 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: 6930928
• MDR Text Key: 89955387
• Report Number: 3005113652-2017-01132
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 94506JR
• Device Lot Number: VB20A60272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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