MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Subcutaneous Nodule (4548)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The filler was injected into the patient and is not accessible for return.The syringe was discarded.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 chin, nasolabial folds, and marionette lines with 1 ml of juvéderm® ultra plus xc.The patient was concomitantly injected in the lips with restylane® kysee.Four months later, the patient experienced ¿late onset inflammation¿ at the injection sites.That day, the patient was treated with a 2 pack of biaxin, valtrex, prednisone taper, and depo medrol.Eleven days later, the patient received hyaluronidase.After another 11 days, the patent was treated with a kenalog/hyaluronidase mixture.Six days later, more kenalog was provided.The event resolved 8 days later.It was noted that ¿kenalog il is what really helped to decrease inflammation and dissolve delayed inflammatory nodules.¿.

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The filler was injected into the patient and is not accessible for return.The syringe was discarded.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 chin, nasolabial folds, and marionette lines with 1 ml of juvéderm® ultra plus xc.The patient was concomitantly injected in the lips with restylane® kysee.Four months later, the patient experienced ¿late onset inflammation¿ at the injection sites.That day, the patient was treated with a 2 pack of biaxin, valtrex, prednisone taper, and depo medrol.Eleven days later, the patient received hyaluronidase.After another 11 days, the patent was treated with a kenalog/hyaluronidase mixture.Six days later, more kenalog was provided.The event resolved 8 days later.It was noted that ¿kenalog il is what really helped to decrease inflammation and dissolve delayed inflammatory nodules.¿.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13082060
• MDR Text Key: 285248728
• Report Number: 3005113652-2021-03487
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Catalogue Number: 94155
• Device Lot Number: H30LB00909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• Treatment: RESTYLANE® KYSEE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female