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 Codes	Detachment Of Device Component (1104); Gel Leak (1267)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional 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.Device history record summary: the documentary research in the batch file shows that no element could explain this issue: all the manufacturing steps are registered as conforming to the specifications.All the syringes are inspected individually after filling and no problem was detected.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).All the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.Device labeling addresses the reported events 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 or Problem Description
Healthcare professional reported during injection with a syringe of juvéderm® ultra xc the needle disengaged and product was lost.Healthcare professional additionally reported ¿bubbles¿ in syringe.No injury to patient or injector.
Additional Manufacturer Narrative
Device analysis: 1 empty syringe of 0.4ml was received without the cap nor needle.No defect was observed.
Event or Problem Description
Healthcare professional reported during injection with a syringe of juvéderm® ultra xc the needle disengaged and product was lost.Healthcare professional additionally reported ¿bubbles¿ in syringe.No injury to patient or injector.

• 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: 6438632
• Report Number: 3005113652-2017-00167
• Device Sequence Number: 565705
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: (01)30888628000074(10)H24LA60338(11)160816(17)180116
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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: 01/16/2018
• Device Catalogue Number: 93899
• Device Lot Number: H24LA60338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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
• Patient Age: 59 YR