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

Catalog Number 94155

Device Problems Clumping in Device or Device Ingredient (1095); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2018

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.Device labeling: precautions: juvéderm® ultra plus xc is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.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.After use, treatment syringes and needles may be potential biohazards.Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.Juvéderm® ultra plus xc injectable gel is a clear, colorless gel without visible particulates.In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify allergan product support at (b)(4).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

Health professional reported that during injection it was noticed that second half of the syringe was "firm" and it had a "blood clot texture¿ for a syringe of juvéderm® ultra plus xc.Patient contact was made.No injury occurred.This record represents one out of four syringes.This is the same event and the same patient reported under mdr id #3005113652-2018-01722 (allergan complaint (b)(4)) and mdr id #3005113652-2018-01723 (allergan complaint (b)(4)).This mdr is being submitted for juvéderm® ultra plus xc.

Manufacturer Narrative

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

Event Description

Health professional reported that during injection it was noticed that second half of the syringe was "firm" and it had a "blood clot texture¿ for a syringe of juvéderm® ultra plus xc.Patient contact was made.No injury occurred.This record represents one out of four syringes.

• 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: 8148484
• MDR Text Key: 130644233
• Report Number: 3005113652-2018-01724
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: 94155
• Device Lot Number: H30LA80187
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR