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

Catalog Number 94703RX

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

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 for the reported event: "warnings ¿ check the expiry date on the product label.".

Event Description

Healthcare professional reported using an expired syringe of juvéderm® volift¿ with lidocaine on a patient.There were no associated injuries or adverse events.

• 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: 6810754
• MDR Text Key: 83313491
• Report Number: 3005113652-2017-00973
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA50285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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