MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Break (1069); Burst Container or Vessel (1074); Gel Leak (1267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

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 device malfunction addressed in the product labeling.

Event Description

Healthcare professional reported a syringe of juvéderm volbella® xc had the ¿top pop off,¿ "tip burst," and ¿come flying¿ during injection, and ¿exploded on the patient¿.Patient contact did occur.No injuries were reported.The packaged needle was used.

Manufacturer Narrative

Device analysis: "empty syringe of 1.0 ml received without plug, no needle.No defect observed to syringe.".

Event Description

Healthcare professional reported a syringe of juvéderm volbella® xc had the ¿top pop off,¿ "tip burst," and ¿come flying¿ during injection, and ¿exploded on the patient.¿ patient contact did occur.No injuries were reported.The packaged needle was used.

• Brand Name: JUVEDERM VOLUMA XC 27G 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: 8273838
• MDR Text Key: 134326772
• Report Number: 3005113652-2019-00028
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2020
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other