MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96181

Device Problems Difficult or Delayed Positioning (1157); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported 1 syringe of juvéderm volbella® xc had a "large amount of pressure" when trying to inject, and the product ended up blowing out "the opposite end" and the product "was coming out where the needle attaches".Patient contact occurred.No injuries were reported.The packaged needle was used.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reported 1 syringe of juvéderm volbella® xc had a "large amount of pressure" when trying to inject, and the product ended up blowing out "the opposite end" and the product "was coming out where the needle attaches." patient contact occurred.No injuries were reported.The packaged needle was used.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• 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: 8202281
• MDR Text Key: 131601439
• Report Number: 3005113652-2018-01776
• Device Sequence Number: 1
• Product Code: LMH
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Catalogue Number: 96181
• Device Lot Number: V15LA70798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other