MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 2X1.0ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96664RX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient in the bilateral nasolabial folds with 2 ml of juvéderm® ultra plus xc.The patient experienced a possible "occlusion" at the injection site the following day.The patient was injected with hyaluronidase the next day, again the following day, and once more 3 days later.The patient has a history of acne and previous unspecified dermal fillers.Event is ongoing, with "significant improvement" occurring.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: d.4., h.6.

Event Description

Healthcare professional reported injecting a patient in the bilateral nasolabial folds with 2 ml of juvéderm® ultra plus xc.The patient experienced a possible "occlusion" at the injection site the following day.The patient was injected with hyaluronidase the next day, again the following day, and once more 3 days later.The patient has a history of acne and previous unspecified dermal fillers.Event is ongoing, with "significant improvement" occurring.

• Brand Name: JUVEDERM ULTRA PLUS XC 2X1.0ML ROW
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15547188
• MDR Text Key: 301238929
• Report Number: 3005113652-2022-00658
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07795316000303
• UDI-Public: 7795316000303
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 96664RX
• Device Lot Number: H30LB10945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female