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

Catalog Number 94154EC

Device Problems Burst Container or Vessel (1074); Gel Leak (1267); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2019

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

Healthcare professional reported injecting a patient with a syringe of juvéderm ultra xc using the packaged needle.At the moment of the injection, the syringe burst and the needle stayed in the patient's skin.The needle was clogged and when it detached, the product leaked.Content was lost.Patient did not experience an adverse event.

Event Description

Healthcare professional reported injecting a patient with a syringe of juvéderm ultra xc using the packaged needle.At the moment of the injection, the syringe burst and the needle stayed in the patient's skin.The needle was clogged and when it detached, the product leaked.Content was lost.Patient did not experience an adverse event.

Manufacturer Narrative

Lab analysis of the device found one empty syringe of 1.0 ml, received with a box and a tray but without needle and cap.No defect is observed on the syringe.

• Brand Name: JUVEDERM ULTRA 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: 8279829
• MDR Text Key: 134325132
• Report Number: 3005113652-2019-00082
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA80219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CONCOMITANT THERAPY
• Patient Outcome(s): Other
• Patient Age: 60 YR