MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 2ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94504JR

Device Problems Shelf Life Exceeded (1567); Detachment of Device or Device Component (2907)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Allergan has initiated an investigation into this late report.See capa (b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device history record summary: the documentary research in the batch file shows that no element could explain this issue: all the manufacturing steps are registered as conforming to the specifications.All the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling addresses the reported event as follows: sterilisation: "the contents of the juvéderm® voluma¿ with lidocaine syringes is sterilised by moist heat.The 23g1" u.T.W.(ultra thin wall) needles are sterilised by ethylene oxide." method of use-posology "juvéderm® voluma¿ with lidocaine 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 and it can therefore no longer be assured.Remove tip cap by pulling it straight off the syringe.Hold the syringe body, firmly insert the needle provided in the package.Firmly attach the needle turning it gently clockwise until you get it well engaged into the syringe luer lock system.Check the needle visually.Holding the syringe body in one hand and the needle cap in the other, pull the two hands in opposite directions to remove it.Inject slowly.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level." warnings: "check the expiry date on the labeling.".

Event Description

Healthcare professional reported during injection to the cheekbones with juvéderm® voluma¿ with lidocaine "while the needle was in the patient's face, the needle detached from the syringe and the content leaked out." the syringe was used past its expiration date.No noted injury to patient or injecting physician.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 2ML
• 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: 6346984
• MDR Text Key: 68087554
• Report Number: 3005113652-2017-00094
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 94504JR
• Device Lot Number: VB20A40111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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