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

Catalog Number 94201JR

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device analysis: visual analysis of the returned device noted no defect. A review of the device history record has been completed. No deviations or non-conformances noted.

Event Description

Healthcare professional reported "during aspiration in the first injection site of a treatment" with juvéderm® volift¿ with lidocaine the plunger rod "was released from its elastic end in the syringe'. No patient impact. Packaged needle was used.

Manufacturer Narrative

Further information from the reporter regarding event, product, and patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event(s) as follows: method of use - posology. Prior to injecting, depress the plunger rod until the product flows out of the needle. Inject slowly and apply the least amount of pressure necessary. After needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular.

Event Description

Healthcare professional reported "during aspiration in the first injection site of a treatment" with juvéderm® volift¿ with lidocaine the plunger rod "was released from its elastic end in the syringe'. No patient impact. Packaged needle was used.

• Brand Name: VOLIFT 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: 6728046
• MDR Text Key: 194995966
• Report Number: 3005113652-2017-00769
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 94201JR
• Device Lot Number: V17LA60574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/20/2017 Patient Sequence Number: 1