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

Catalog Number 94155

Device Problems Difficult or Delayed Positioning (1157); Expulsion (2933)

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

Event Date 06/08/2018

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.A review of the device history record has been completed.No deviations or non-conformance's noted.Device labeling: precautions: juvéderm® ultra plus 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: inject juvéderm® ultra plus xc applying even pressure on the plunger rod while slowly pulling the needle backward.The wrinkle should be lifted and eliminated by the end of the injection.It is important that the injection be stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.How supplied: juvéderm® ultra plus xc injectable gel is supplied in individual treatment syringes with 27-g needles for single-patient use and ready for injection (implantation).The volume in each syringe is as stated on the syringe label and on the carton.The contents of the syringe are sterile and non-pyrogenic.Do not resterilize.Do not use if package is opened or damaged.

Event Description

Healthcare professional reported after injection, one syringe of juvéderm® ultra plus xc had issue with product extruding from syringe.Injector changed needles during injection.Second needle would not extrude product, so the injector exchanged needle again and product "came down/out of syringe".Patient contact was made, but no injury occurred to patient, staff, or injector.The packaged needle was not used.

Manufacturer Narrative

Device analysis: empty syringe of 1.0 ml received with a cap, no needle in an opened blister & pack.The plunger rod is disconnected from syringe.The plunger tip is still inside at the 0.1 ml graduation.

Event Description

Healthcare professional reported after injection, one syringe of juvéderm® ultra plus xc had issue with product extruding from syringe.Injector changed needles during injection.Second needle would not extrude product, so the injector exchanged needle again and product "came down/out of syringe." patient contact was made, but no injury occurred to patient, staff, or injector.The packaged needle was not 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
• MDR Report Key: 7648147
• MDR Text Key: 113008094
• Report Number: 3005113652-2018-00804
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: 94155
• Device Lot Number: H30LA70620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR