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

Catalog Number 94731RX

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

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

Event Description

Physician reports that upon starting the application of juvéderm® volbella¿ with lidocaine, after "putting the needle, the tip of the syringe was fractured, the thread was normally grasped, application begun and immediately, physician noticed that the plunger was blocked".It was noted that the syringe has more than a half of its content.Fracture of the syringe in the union with the needle (luer lock).The device touched the patient and patient experienced no consequence.Packaged needle used.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: one empty syringe of 1.0 ml was received with a tray, but without needle and cap.Two cracks were observed at the 3 mm luer lock level.

Event Description

It was clarified that "when the physician opened the syringe it was already fractured.".

• 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: 8199170
• MDR Text Key: 131504777
• Report Number: 3005113652-2018-01846
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA80125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR