MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155EC

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

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.

Event Description

Healthcare professional reported having a syringe of juvederm ultra plus xc that burst when they tried to fit a cannula soft fil 25g.The device was also "outflowing" despite the cannula being correctly fixed during the injection.There were no injuries.

Manufacturer Narrative

Without tray, needle and cap.No default observed on the syringe.

Event Description

Healthcare professional reported having a syringe of juvéderm ultra plus xc that burst when they tried to fit a cannula soft fil 25g.The device was also "outflowing" despite the cannula being correctly fixed during the injection.There were no injuries.

• Brand Name: JUVEDERM ULTRA PLUS XC 1 ML ROW
• 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: 8222875
• MDR Text Key: 132568445
• Report Number: 3005113652-2018-01860
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 94155EC
• Device Lot Number: H30LA80069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR