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

Catalog Number 94154

Device Problems Crack (1135); Gel Leak (1267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2019

Event Type  malfunction  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.Device analysis: one syringe of 1.0 ml with 0.15 ml of gel remaining, received with a plastic flag and a cap but without tray and needle.Cracks are observed at the 3 mm luer lock level.A plastic part is missing.A review of the device history record has been initiated.If any deviations or non-conformance are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported during injection with one syringe of juvéderm® ultra xc the syringe cracked and the product went all over the patients¿ face.Patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.

• Brand Name: JUVEDERM ULTRA 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: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8441166
• MDR Text Key: 139543571
• Report Number: 3005113652-2019-00249
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA70759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other