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

Catalog Number	94154
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting a patient in the lips with.3 cc of juvéderm® ultra xc.The patient experienced ¿vascular occlusion¿ at the injection site that day.Three days later, the patient was treated at another office with hylenex, antibiotics, prednisone, and valtrex.An ultrasound was performed by a different healthcare professional, and the results noted as ¿dark area around lateral aspect of sli which appeared compressed by hyaluronic acid.Inferior aspect of columellar artery that meets at top of patient¿s gk point also dark.¿ another ultrasound was performed the next day with the results noted as ¿ultrasound: medial portion of upper lip, at the gk point and the philtral column sluggish.Cap refill.Color dopler showed perfusion of vessels ¿ septal branch and columellar branch.¿ the event resolved 3 days later, but after 5 days, the patient was started on cutagenix topical and a total of 1800 units of hylenex and 1500 of hyaluronidase.The event improved.
Additional Manufacturer Narrative
Suspect product: lot number 963/2.(b)(4).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 injecting a patient in the lips with.3 cc of juvéderm® ultra xc.The patient experienced ¿vascular occlusion¿ at the injection site that day.Three days later, the patient was treated at another office with hylenex, antibiotics, prednisone, and valtrex.An ultrasound was performed by a different healthcare professional, and the results noted as ¿dark area around lateral aspect of sli which appeared compressed by hyaluronic acid.Inferior aspect of columellar artery that meets at top of patient¿s gk point also dark.¿ another ultrasound was performed the next day with the results noted as ¿ultrasound: medial portion of upper lip, at the gk point and the philtral column sluggish.Cap refill.Color dopler showed perfusion of vessels ¿ septal branch and columellar branch.¿ the event resolved 3 days later, but after 5 days, the patient was started on cutagenix topical and a total of 1800 units of hylenex and 1500 of hyaluronidase.The event improved.

• 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: 16137497
• Report Number: 3005113652-2023-00007
• Device Sequence Number: 20517400
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: 94154
• Device Lot Number: 1000510633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female