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

Catalog Number	94155
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect product: lot number 963/3 type of investigation code: b15, b18, b20.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe has been 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.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a patient was injected with one syringe of juvéderm® ultra plus xc and botox in the glabellar lines.Three days later, patient contacted the healthcare professional with photographs.The healthcare professional observed signs of necrosis and recommended that the patient go to the emergency room.The patient was treated in the er with antibiotics and hylenex.The syringe has been discarded and the current status of the symptoms is unknown.
Event or Problem Description
Healthcare professional reported a patient was injected with one syringe of juvéderm® ultra plus xc and botox in the glabellar lines.Three days later, patient contacted the healthcare professional with photographs.The healthcare professional observed signs of necrosis and recommended that the patient go to the emergency room.The patient was treated in the er with antibiotics and hylenex.The syringe has been discarded and the current status of the symptoms is unknown.

• Brand Name: JUVEDERM ULTRA PLUS 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: 16659282
• Report Number: 3005113652-2023-00228
• Device Sequence Number: 13878223
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: 94155
• Device Lot Number: 1000539322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 04/01/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: BOTOX
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male