MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

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: 5.Precautions ¿ juvéderm voluma® xc is packaged for single-patient use.Do not resterilize.Do not use if package is open 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 6.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.

Event Description

Healthcare professional reported one syringe of juvéderm voluma® xc had ¿the product became very hard¿ and would not push out of the syringe.The healthcare professional went on to advised that the needle ¿exploded off and the product spilled out.¿ patient contact occurred.No injuries were reported.The packaged needle was used and this was the confirmed initial use of the syringe.

Manufacturer Narrative

Device analysis summary: visual analysis of the device indicates no defect observed.

Event Description

Healthcare professional reported one syringe of juvéderm voluma® xc had ¿the product became very hard¿ and would not push out of the syringe.The healthcare professional went on to advised that the needle ¿exploded off and the product spilled out.¿ patient contact occurred.No injuries were reported.The packaged needle was used and this was the confirmed initial use of the syringe.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• Type of Device: 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: 7437920
• MDR Text Key: 105767755
• Report Number: 3005113652-2018-00406
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A70637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR