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

Catalog Number 94154EC

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

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.

Event Description

Healthcare professional reported having a syringe of juvéderm ultra xc with a defect.Device made contact with the patient but no product was injected.It was impossible to aspirate due to the defective syringe.Patient was to be injected in the nasogenian grove.There were no reported injuries.

Event Description

Additional information: the packaged needle was attached to the syringe.When aspirating the product, the needle was released.It had been clarified that the device did not touch the patient.

Manufacturer Narrative

Additional information: date of event.

Event Description

Healthcare professional reported having a syringe of juvéderm ultra xc with a defect.Device made contact with the patient but no product was injected.It was impossible to aspirate due to the defective syringe.Patient was to be injected in the nasogenian grove.There were no reported injuries.

Manufacturer Narrative

Lab analysis of the device found one full syringe of 1,0 ml received in an open tray but whitout cap and needle.No default 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: 8217575
• MDR Text Key: 132225894
• Report Number: 3005113652-2018-01814
• 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,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA80131
• 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