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

Catalog Number 96183

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2018

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 one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked".Patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.

Event Description

Healthcare professional reported one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked." patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.

Manufacturer Narrative

Device analysis: visual analysis of the device indicates empty syringe of 1.0 ml received with needle still attached to syringe in an opened tray.No defect observed to syringe.

• 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: 8297062
• MDR Text Key: 134743349
• Report Number: 3005113652-2019-00060
• 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: 03/08/2019

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: 06/02/2020
• Device Catalogue Number: 96183
• Device Lot Number: V15LA80469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 03/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR