MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151ED

Device Problems Connection Problem (2900); Expulsion (2933)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2018

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.Device labeling: "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 having a syringe of juvéderm voluma with lidocaine with a faulty thread and there was leaking at the hub.It was noted that the thread was not working.Both the packaged needle and a 25g dermasculpt cannula were used.The needle had been inserted into the patient's right cheek when the event occurred.The plunger was pressed but there was no lift to the patient's cheek and it was then noticed that the filler was leaking out from the "junction of the hub of the syringe and the needle." there were no injuries.

Manufacturer Narrative

Lab analysis of the device found no defect.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reported having a syringe of juvéderm voluma with lidocaine with a faulty thread and there was leaking at the hub.It was noted that the thread was not working.Both the packaged needle and a 25g dermasculpt cannula were used.The needle had been inserted into the patient's right cheek when the event occurred.The plunger was pressed but there was no lift to the patient's cheek and it was then noticed that the filler was leaking out from the "junction of the hub of the syringe and the needle." there were no injuries.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7606702
• MDR Text Key: 112147209
• Report Number: 3005113652-2018-00683
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 94151ED
• Device Lot Number: VB20A70836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR