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 Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information from the reporter regarding the event, product, or patient details has been requested.No additional information is available at this time.Device labeling: precautions: ¿ 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.¿ 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.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
Company representative reported during injection of 1 syringe of juvéderm® ultra xc ¿the needle popped off while injecting." patient contact was made.No injury to patient, staff, or injector.The packaged needle was used.
Additional Manufacturer Narrative
Device analysis: "empty syringe of 0.4 ml received without cap, no needle.No defect observed to syringe.".
Event or Problem Description
Company representative reported during injection of 1 syringe of juvéderm® ultra xc ¿the needle popped off while injecting." patient contact was made.No injury to patient, staff, or injector.The packaged needle was used.

• 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: 6982011
• Report Number: 3005113652-2017-01298
• Device Sequence Number: 13484385
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: (01)30888628000074(10)H24LA70141(11)170315(17)180815
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 08/15/2018
• Device Catalogue Number: 93899
• Device Lot Number: H24LA70141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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