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

Catalog Number	94154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Nodule (4551)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported a patient was injected in the lips with 1ml of juvéderm® ultra xc, in the lips with one syringe juvéderm® ultra plus xc.Approximately two months later, patient experienced ¿lump and swelling" on the upper left-side lip with "discomfort, and burning" in the lips and hcp treated the patient with.01mls of hylenex®.Approximately nine months later, patient was injected with 0.5 ml in lips and 0.5ml in cheeks of juvéderm® ultra xc.The patient experienced central area of "slight inflammation and bruising¿.On unspecific time later, patient was injected in the lips with 0.25ml of an unknown juvéderm product.The patient experienced ¿small bump, pustule, and ulceration" to the upper lip.Events are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2023-00884 (abbvie complaint #(b)(4)), mdr id# 3005113652-2023-00887 (abbvie complaint #(b)(4)), mdr id# 3005113652-2023-00885 (abbvie complaint #(b)(4)).This mdr is being submitted for the 3rd suspect product, juvéderm® ultra xc.
Additional Manufacturer Narrative
Continued h.6.Type of investigation code: b15, b18, b20.Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.The event is a physiological complication and analysis of the device generally does not assist abbvie 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.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM ULTRA XC TSK US
• Common Device Name: 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: 18117191
• Report Number: 3005113652-2023-00886
• Device Sequence Number: 7502794
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2020
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESTROGEN AND A TESTOSTERONE HORMONE.
• Patient Sex: Female