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

Catalog Number 94154

Device Problem Migration (4003)

Patient Problem Nodule (4551)

Event Type  Injury  

Manufacturer Narrative

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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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 that ¿the patient developed a granuloma and nodule around the upper lip, and chin¿, and ¿the filler has migrated, and has caused a significant amount of inflammation¿ approximately 3 months after they were injected in the lips and perioral area with two syringes of juvéderm® ultra xc.Biopsy was not provided.Treatment is noted as benadryl, dexamethasone, keflex/steroids, and hylenex.It was noted that the ¿patient didn¿t finish course and nodules have gotten worse/considering possible granuloma.¿.

Event Description

Healthcare professional reported that ¿the patient developed a granuloma and nodule around the upper lip, and chin¿, and ¿the filler has migrated, and has caused a significant amount of inflammation¿ approximately 3 months after they were injected in the lips and perioral area with two syringes of juvéderm® ultra xc.Biopsy was not provided.Treatment is noted as benadryl, dexamethasone, keflex/steroids, and hylenex.It was noted that the ¿patient didn¿t finish course and nodules have gotten worse/considering possible granuloma.¿.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: JUVEDERM ULTRA 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: 14681729
• MDR Text Key: 294877815
• Report Number: 3005113652-2022-00304
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB10554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female