MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (2 X 0.4 ML); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	93899
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2018
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 initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device labeling: precautions: ¿juvéderm® ultra xc is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.¿juvéderm® ultra 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.¿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 xc by applying even pressure on the plunger rod while slowly pulling the needle backwards.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 xc injectable gel is supplied in individual treatment syringes with 30 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 or Problem Description
Healthcare professional called to report during injection, one syringe of juvéderm® ultra xc had a needle disengagement.Patient contact was made.No injury occurred.The allergan packaged needle was used and tightened by hand.This was confirmed the initial use of the syringe.The syringe is available for return.
Additional Manufacturer Narrative
Device analysis: 1 empty syringe of 0.4ml received without cap nor needle.No defect observed.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional called to report during injection, one syringe of juvederm ultra xc had a needle disengagement.Patient contact was made.No injury occurred.The allergan packaged needle was used and tightened by hand.This was confirmed the initial use of the syringe.The syringe is available for return.

• Brand Name: JUVEDERM ULTRA XC (2 X 0.4 ML)
• 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: 8033613
• Report Number: 3005113652-2018-01448
• Device Sequence Number: 1463640
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: 30888628000074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/17/2018

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: 08/13/2019
• Device Catalogue Number: 93899
• Device Lot Number: H24LA80171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: 54 YR