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

Catalog Number 94640

Device Problems Activation, Positioning or Separation Problem (2906); Expulsion (2933)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

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: precautions: ¿ juvéderm voluma® xc 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 surveillance at (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 Description

Healthcare professional reported during injection, one syringe of juvéderm voluma® xc had an issue where the "product backed up out of the hub" and spilled on the patient.Patient contact was made, but no injury to patient, staff, or injector occurred.The packaged needle was used.

Manufacturer Narrative

Device analysis: "1 syringe of 1.0ml with 0.3ml of gel remaining received in an opened pack with an opened tray without cap nor needle.No defect observed.".

Event Description

Healthcare professional reported during injection, one syringe of juvéderm voluma® xc had an issue where the "product backed up out of the hub" and spilled on the patient.Patient contact was made, but no injury to patient, staff, or injector occurred.The packaged needle was used.

• 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: 7558485
• MDR Text Key: 109756838
• Report Number: 3005113652-2018-00640
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A70801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR