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

Catalog Number 94154

Device Problems Activation, Positioning or Separation Problem (2906); Expulsion (2933)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "not happy with the results" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device analysis: visual analysis of the returned device noted no defect was observed.Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling addresses the reported event(s) as follows: "precautions: 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.".

Event Description

Healthcare professional reported during injection with 1 syringe of juvéderm® ultra xc the plunger malfunctioned and the product spilled over the patient.No injury was reported; however, the patient called them approximately 3-4 days after injection and stated they were not happy with the results.Further follow up with the healthcare professional a few weeks later revealed patient is "now happy with the results.".

Event Description

Additional information from the healthcare professional: patient was concomitantly taking omeprazole and zyrtec with the injection.Injection site locations were in the marionette lines and oral commissures.

• 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: 6522020
• MDR Text Key: 74041871
• Report Number: 3005113652-2017-00257
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: (01)30888628000081(10)H24LA70018(11)170120(17)180620
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 94154
• Device Lot Number: H24LA70018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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: 52 YR