MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling for the reported event of detachment of device component and difficult to remove: "5.Precautions failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.".

Event Description

Healthcare professional reported that during injection of 1 syringe of juvéderm® ultra xc, ¿the 30g needle snapped off the hub and remained in the patient.¿ the patient will undergo exploration of the area and surgical removal of the needle at the earliest convenience.The packaged needle was used.There were no reported injuries.

Manufacturer Narrative

Device evaluation: 1.0 ml syringe with 0.75 ml of gel remaining in it received with a cap, one used needle.No defect observed to syringe.

Event Description

Healthcare professional reported that during injection of 1 syringe of juvéderm® ultra xc, ¿the 30g needle snapped off the hub and remained in the patient.¿ the patient will undergo exploration of the area and surgical removal of the needle at the earliest convenience.The packaged needle was used.There were no reported injuries.

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 7284088
• MDR Text Key: 100486729
• Report Number: 3005113652-2018-00166
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA70567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR