MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96183

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2019

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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that prior to injection with one syringe of juvéderm® volbella® xc, ¿the injector didn¿t get any product out of the syringe because of a crack was found in the grey stopper of the plunger.The injector didn¿t want to inject the patient with a crack in the syringe because of possible contamination.¿.

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.Device evaluation: "1.0 ml syringe filled at 0.55 ml with 0.4 m of gel remaining in it received with a cap, 2 unused needles in an opened tray.A crack is observed at the 3 mm luer lock level.Syringe has been used as some gel is present in the luer lock and on cap.".

Event Description

Healthcare professional reported that prior to injection with one syringe of juvéderm® volbella® xc, ¿the injector didn¿t get any product out of the syringe because of a crack was found in the grey stopper of the plunger.The injector didn¿t want to inject the patient with a crack in the syringe because of possible contamination.¿.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: 8612950
• MDR Text Key: 145642328
• Report Number: 3005113652-2019-00357
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: 96183
• Device Lot Number: V15LA80531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other