MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154EC

Device Problems Leak/Splash (1354); Fitting Problem (2183)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.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.Inject slowly.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level.'.

Event Description

Healthcare professional reported to a company representative that while using 1 syringe of juvéderm® ultra xc¿, there was a "failure in fitting and loss of almost 0.8ml of product." the product leaked through the luer lock.Packaged needle was used.Patient contact occurred; no injuries reported.

Manufacturer Narrative

Device analysis: 1 empty syringe of 1.0ml received in an opened pack with an opened tray along with the cap and two needles.No defect observed.

Event Description

Healthcare professional reported to a company representative that while using 1 syringe of juvéderm® ultra xc¿, there was a "failure in fitting and loss of almost 0.8ml of product." the product leaked through the luer lock.Packaged needle was used.Patient contact occurred; no injuries reported.

• Brand Name: JUVEDERM ULTRA XC 1 ML ROW
• 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: 6969808
• MDR Text Key: 90769229
• Report Number: 3005113652-2017-01301
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P050047
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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: 94154EC
• Device Lot Number: H24LA70270
• 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: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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
• Patient Age: 33 YR