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

Catalog Number 94151EC

Device Problems Burst Container or Vessel (1074); Loose or Intermittent Connection (1371); Expulsion (2933)

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

Event Date 10/04/2017

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 addresses the reported event(s) as follows: "method of use-posology ¿ remove tip cap by pulling it straight off the syringe as shown in fig.1.Then firmly push the needle provided in the box (fig.2) into the syringe, screwing it gently clockwise.Twist once more until it is fully locked and has the needle cap in the position shown in fig.3.If the needle cap is positioned as shown in fig.4, it is incorrectly attached.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig.5, and pulling the two hands in opposite directions.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.".

Event Description

Healthcare professional reported during injection with 1 syringe of juvéderm® voluma¿ with lidocaine into the left malar area, they ¿put the cannula 25g through the hole¿ and started the compression of the plunger.Healthcare professional reported that ¿suddenly, the thread of the syringe collapsed (bursting noise), the cannula fitting loosened and almost all material was lost around the syringe and no product was injected.¿ according to the healthcare professional, there was a possible ¿failure of the syringe thread.¿ no injuries occurred to the patient, injector, or staff.A juvéderm® voluma¿ with lidocaine syringe from the same box was used on the patient¿s right side with no intercurrences.

Manufacturer Narrative

Device analysis: two empty syringes of 1.0 ml each received with caps, no needles.No defect observed to both syringes.

Event Description

Healthcare professional reported during injection with 1 syringe of juvéderm® voluma¿ with lidocaine into the left malar area, they ¿put the cannula 25g through the hole¿ and started the compression of the plunger.Healthcare professional reported that ¿suddenly, the thread of the syringe collapsed (bursting noise), the cannula fitting loosened and almost all material was lost around the syringe and no product was injected.¿ according to the healthcare professional, there was a possible ¿failure of the syringe thread.¿ no injuries occurred to the patient, injector, or staff.A juvéderm® voluma¿ with lidocaine syringe from the same box was used on the patient¿s right side with no intercurrences.

• 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: 6985465
• MDR Text Key: 91093440
• Report Number: 3005113652-2017-01322
• 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,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A70273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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