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

Catalog Number 94151ED

Device Problems Short Fill (1575); Component Missing (2306); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Lab analysis of the device: 1 syringe of juvederm ultra xc (lot h24la60076) in a pack of juvederm voluma with lidocaine (lot vb20a60523) was received.1.0 ml used syringe with 0.5 ml of gel remaining in it received with a cap, no needle in a voluma with lidocaine pack (vb20a60523).No defect observed to syringe, nor to remaining gel.Device history record summary: the documentary research in the batch file shows that no element could explain these issues: all the syringes are inspected individually after filling and no problem was detected.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).All the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conform to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.The production line clearance done on each batch was in conformity and the double check performed at end of batch by 2 different operators was conforming.These 2 batches were not manufactured at same time, it is impossible that stickers of vb20a60523 could be found in a pack of h24la60076, as the lot vb20a60523 was manufactured 8 months later.It is hypothesized that there was a mix up at the physician's office, but cannot be ascertained.Device labeling addresses the reported events as follows: composition: one syringe contains 1 ml of juvéderm® voluma® with lidocaine.Description: juvéderm® voluma® with lidocaine is a sterile, pyrogen-free physiological solution of cross-linked hyaluronic acid (ha) which is not of animal origin.The gel is presented in a graduated, pre-filled, disposable syringe.Each box contains two 1 ml juvéderm® voluma® with lidocaine syringes, 4 single- use 27g/1/2¿ sterile needles to be used only for injecting juvéderm® voluma® with lidocaine, an instruction leaflet, and a set of labels in order to ensure traceability.

Event Description

Healthcare professional reported having a box of juvéderm® voluma® with lidocaine which had 2 syringes, but 1 of the syringes was "only half-full with product." there was also only one needle in the tray with the half full syringe.The box was still sealed when the syringes were found.Both packaging trays were also sealed.The syringe was also labeled as juvéderm ultra® xc.The device was not used.This is the same event reported under mdr id #3005113652-2017-00613 ((b)(4)).This is the first mdr submitted for the first suspected product, juvéderm® voluma® with lidocaine.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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: 6679377
• MDR Text Key: 78789910
• Report Number: 3005113652-2017-00612
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 94151ED
• Device Lot Number: VB20A60523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other