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

Catalog Number 94154

Device Problems Coagulation in Device or Device Ingredient (1096); Detachment Of Device Component (1104); Crack (1135)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time device labeling: 5.Precautions ¿ juvéderm® ultra xc is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.¿ 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.8.Instructions for use b.Health care professional instructions 9.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.

Event Description

Healthcare professional reported during injection with juvéderm® ultra xc the syringe cracked.Healthcare professional additionally noted the filler was too thick to pass through syringe and popped off needle with remainder of product abruptly part way through treatment, not while in contact with patient.No injury to patient or staff reported.The packaged needle was used.

Manufacturer Narrative

Device analysis summary: visual analysis of the device indicated a bubble outside specification is observed near the luer lock level.

Event Description

Healthcare professional reported during injection with juvéderm® ultra xc the syringe cracked.Healthcare professional additionally noted the filler was too thick to pass through syringe and popped off needle with remainder of product abruptly part way through treatment, not while in contact with patient.No injury to patient or staff reported.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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6988586
• MDR Text Key: 91205755
• Report Number: 3005113652-2017-01315
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: (01)30888628000081(10)H24LA60471(11)161027(17)180327
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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: 03/27/2018
• Device Catalogue Number: 94154
• Device Lot Number: H24LA60471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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: 58 YR