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

Catalog Number 94151EC

Device Problems Fracture (1260); Fitting Problem (2183); Expulsion (2933)

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

Event Date 08/30/2017

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.Then firmly push the needle provided in the box into the syringe, screwing it gently clockwise.Twist once more until it is fully locked.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other 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 to a company representative that ¿when placing the cannula in the device (juvéderm¿ voluma¿ with lidocaine), the cannula did not fit properly¿ and ¿when applying the product, it comes out through [t]he sides between the syringe thread and the cannula.¿ healthcare professional further described ¿placing the cannula into the top of the device, but it did not spin the normal amount (in depth)¿ and when ¿putting a little more pressure¿ on it, ¿smoothly, the syringe fissured at the tip.¿ product came out between the cannula and the syringe.0.1cc injected in the cheeks, ck1, ck2, and ck3.Packaged needle and a 25g cannula were used.Patient contact was made; no injuries reported.Healthcare professional did not continue to spin the cannula, but the product started to come out through the edge, so the healthcare professional changed the needle.

• 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: 6916035
• MDR Text Key: 89464453
• Report Number: 3005113652-2017-01182
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 10/04/2017

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: 08/31/2018
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A60396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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
• Patient Age: 50 YR