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

Catalog Number	93897
Medical Device Problem Codes	Detachment Of Device Component (1104); Expulsion (2933)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional 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-conformances noted.Device labeling: precautions: ¿ juvéderm® ultra injectable gel is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.¿juvéderm® ultra 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.¿juvéderm® ultra 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 1-877-345-5372.¿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: ¿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 1 syringe of juvéderm® ultra had ¿the needle disengaged and the needle was stuck in the patient¿s face with the filler everywhere.¿ patient contact was made, but there was no injury to patient, staff, or injector.The packaged needle was used.

• Brand Name: JUVEDERM ULTRA
• 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: 7561482
• Report Number: 3005113652-2018-00650
• Device Sequence Number: 131096
• Product Code: LMH
• UDI-Device Identifier: 30888628000036
• UDI-Public: 30888628000036
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 10/18/2018
• Device Catalogue Number: 93897
• Device Lot Number: HV24A60495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/01/2018
• 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
• Patient Age: 50 YR