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	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported that a patient was injected with juvéderm® ultra.The left side of the lip began ¿turning blue,¿ noting a ¿vascular occlusion.¿ the injection was stopped, and the patient was treated with hylenex.Additionally, the healthcare professional reported that after injecting a patient in the left upper lip after applying dental blocker for numbing and.8 cc of juvéderm® ultra xc were injected, the patient experienced a ¿vascular occlusion¿ in the lip.The patient was immediately treated with 150 u of hylenex, heat was applied, and the patient was massaged.The patient had slight improvement although there was bruising, ¿possibly from the aggressive massaging.¿ the next day, the capillary refill of the patient was still slow, so another 150 u of hylenex were used and the patient was massaged again.The patient was followed up for a week.The event resolved 11 days post-onset.
Additional Manufacturer Narrative
Suspect product: lot number 963/2.Investigation code: b15, b17, b20 type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.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.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported that a patient was injected with juvéderm® ultra.The left side of the lip began ¿turning blue,¿ noting a ¿vascular occlusion.¿ the injection was stopped, and the patient was treated with hylenex.Additionally, the healthcare professional reported that after injecting a patient in the left upper lip after applying dental blocker for numbing and.8 cc of juvéderm® ultra xc were injected, the patient experienced a ¿vascular occlusion¿ in the lip.The patient was immediately treated with 150 u of hylenex, heat was applied, and the patient was massaged.The patient had slight improvement although there was bruising, ¿possibly from the aggressive massaging.¿ the next day, the capillary refill of the patient was still slow, so another 150 u of hylenex were used and the patient was massaged again.The patient was followed up for a week.The event resolved 11 days post-onset.

• 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: 17638594
• Report Number: 3005113652-2023-00694
• Device Sequence Number: 15349750
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 04/03/2024
• Device Catalogue Number: 94154
• Device Lot Number: 1000552343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: ANTIDEPRESSANTS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 75 KG