MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Detachment Of Device Component (1104); Gel Leak (1267); Material Integrity Problem (2978)

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

Event Date 02/28/2017

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 history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.All the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.Device labeling addresses the reported event(s) as follows: "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 with one syringe of juvéderm voluma® xc healthcare professional had the ¿tip of the syringe blow off,¿ the ¿needle disengaged,¿ and the product, ¿spilled.¿ patient contact did occur.No injury to patient, staff, or injector.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 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: 6425333
• MDR Text Key: 70638599
• Report Number: 3005113652-2017-00151
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A60498(11)161115(17)180415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2018
• Device Catalogue Number: 94640
• Device Lot Number: VB20A60498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 29 YR