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

Catalog Number 94728II

Device Problems Backflow (1064); Detachment Of Device Component (1104)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/08/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: method of use ¿ posology ¿ juvéderm® volbella¿ with lidocaine is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.

Event Description

Healthcare professional reported injecting a patient with juvéderm volbella with lidocaine in the tear trough (tt2) using the packaged needle.While aspirating at the injection site, the plunger came detached from the syringe and the vacuum release in the syringe led to blood coming into the syringe.Injection was aborted.There was only blood in the syringe due to the vacuum release and there was no bleeding after the removal of the needle from the site of injection.There were no injuries or adverse reactions.

Event Description

Healthcare professional reported injecting a patient with juvéderm volbella with lidocaine in the tear trough (tt2) using the packaged needle.While aspirating at the injection site, the plunger came detached from the syringe and the vacuum release in the syringe led to blood coming into the syringe.Injection was aborted.There was only blood in the syringe due to the vacuum release and there was no bleeding after the removal of the needle from the site of injection.There were no injuries or adverse reactions.

Manufacturer Narrative

Lab analysis of the device found 1 empty syringe of 1.0ml received in an opened tray with cap and without needle.The plunger rod is disconnected.

• Brand Name: JUVEDERM VOLBELLA WLIDOCAINE 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: 7565577
• MDR Text Key: 110033530
• Report Number: 3005113652-2018-00634
• 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: 08/23/2018

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: 07/31/2019
• Device Catalogue Number: 94728II
• Device Lot Number: V15LA70473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other