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

Catalog Number 94506KO

Device Problems Break (1069); Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 issues: all the syringes are inspected individually after filling and no problem was detected.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling for the reported event: "method of use: this product is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.Warnings: check the expiry date on the product label.[expiration date] refer to the use by date ( ) on the label at the side of the product packing box".

Event Description

Healthcare professional reported injecting a patient with juvéderm® voluma® with lidocaine in the forehead using the packaged needle.The syringe was "broken at luer lock" while changing the needle.The use of the device was approximately 2 years after the expiration date.There were no reported injuries.

Manufacturer Narrative

Device analysis: the 3mm luer lock is broken and a small part of plastic is missing.

Event Description

Healthcare professional reported injecting a patient with juvéderm® voluma® with lidocaine in the forehead using the packaged needle.The syringe was "broken at luer lock" while changing the needle.The use of the device was approximately 2 years after the expiration date.There were no reported injuries.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1 ML
• 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: 6461590
• MDR Text Key: 71768382
• Report Number: 3005113652-2017-00205
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 94506KO
• Device Lot Number: VB20A30210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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: 36 YR