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

Catalog Number 94155

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2019

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 analysis: "one syringe of 1.0 ml with 0.55 ml of gel remaining, received with a cap but without tray and needle.White particles are observed into the remaining gel".

Event Description

Healthcare professional reported that prior an injection with ¿one juvéderm® ultra plus xc, ¿weird little white particles in the gel in the syringe¿.No contact and no injury to the patient or injector.The issue was found prior to the use of the syringe.

Event Description

Healthcare professional reported that prior an injection with ¿one juvéderm® ultra plus xc, ¿weird little white particles in the gel in the syringe.¿ no contact and no injury to the patient or injector.The issue was found prior to the use of the syringe.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

• 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
• MDR Report Key: 8437626
• MDR Text Key: 139543680
• Report Number: 3005113652-2019-00257
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: 09/24/2019
• Device Catalogue Number: 94155
• Device Lot Number: H30LA80316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other