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

Catalog Number 96181

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional reported that during injection with one syringe of juvéderm volbella® xc, "it was noticed that the product had a hard-white object floating in the product within the syringe." patient contact occurred.There were no injuries to patient or injector.The allergan packaged needle was used and tightened by hand.This was confirmed the initial use of the syringe.

Event Description

Healthcare professional reported that during injection with one syringe of juvéderm volbella® xc, "it was noticed that the product had a hard-white object floating in the product within the syringe." patient contact occurred.There were no injuries to patient or injector.The allergan packaged needle was used and tightened by hand.This was confirmed the initial use of the syringe.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, corrected, and/or changed data: d.4., h.6.

• 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: 10316029
• MDR Text Key: 200292221
• Report Number: 3005113652-2020-00415
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: 10/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 96181
• Device Lot Number: V15LA90351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other