MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155

Device Problems Positioning Failure (1158); Expulsion (2933)

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

Event Date 12/05/2017

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: precautions: ¿ juvéderm® ultra xc 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.¿ failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.Instructions for use: ¿ if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.

Event Description

Health professional reported that about a quarter of the way through the injection with one syringe of juvéderm® ultra xc the product stopped going through the needle and it came out of the luer lock.No injury to the patient or injector.The needle from the package was used.

Manufacturer Narrative

Device analysis: visual analysis of the returned device noted no defect was observed to syringe.

Event Description

Health professional reported that about a quarter of the way through the injection with one syringe of juvéderm® ultra xc the product stopped going through the needle and it came out of the luer lock.No injury to the patient or injector.The needle from the package was used.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 7151658
• MDR Text Key: 96023806
• Report Number: 3005113652-2017-01727
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Catalogue Number: 94155
• Device Lot Number: H30LA70441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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: 28 YR