MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94728JR

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding event details has been requested.No additional information is available at this time.Device labeling addresses the reported event as follows: method of use ¿ posology ¿ "juvéderm® volbella¿ with lidocaine 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.".

Event Description

Patient reported they were injected "in order to fill in the area below the eyes, due to lack of adipose tissue" with juvéderm® volbella¿ with lidocaine.The patient "observed and reported that the product which was administered to [them] had expired since january.The patient's physician claimed that the product remains effective for one year after the expiration date.The patient has presented with no adverse events so far.".

Manufacturer Narrative

(b)(4).Device history record summary: the documentary research in the batch file shows that no element could explain this issue: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.

Event Description

Patient reported they were injected "in order to fill in the area below the eyes, due to lack of adipose tissue" with juvéderm® volbella¿ with lidocaine.The patient "observed and reported that the product which was administered to [them] had expired since january.The patient's physician claimed that the product remains effective for one year after the expiration date.The patient has presented with no adverse events so far.".

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: 6631202
• MDR Text Key: 77433858
• Report Number: 3005113652-2017-00508
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA50066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• 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: 34 YR