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

Catalog Number	93900
Medical Device Problem Codes	Detachment Of Device Component (1104); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional 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 plus 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 8.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.
Event or Problem Description
Healthcare professional reported during injection with juvéderm® ultra plus xc the product "started coming out where the needle attaches to the syringe." patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
Event or Problem Description
Healthcare professional reported during injection with juvéderm® ultra plus xc the product "started coming out where the needle attaches to the syringe." patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
Additional Manufacturer Narrative
Device analysis summary: visual analysis of the device indicates no defect observed.

• Brand Name: JUVEDERM ULTRA PLUS XC
• Common Device Name: 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: 7278680
• Report Number: 3005113652-2018-00156
• Device Sequence Number: 16645801
• Product Code: LMH
• UDI-Device Identifier: 30888628000104
• UDI-Public: 30888628000104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 93900
• Device Lot Number: H30LA70510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other