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

Catalog Number	94154
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued h.6.Type of investigation code: b15, b18, b20.Continued h.6.Investigation conclusions code: d1101, d1102.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported that they were injected in the nasolabial folds with 0.1 ml of juvéderm® ultra xc with a re-use of the syringe.A few hours later, patient experienced purple dots, pain, and vascular occlusion type symptoms on the under left eye.Their nose had a bluish tone on the left side.Patient went back to the office and was treated with a warm compress, 20 units of hylenex in quadrant where filler was injected, and advised to take 300 mg of aspirin in the morning.The patient had taken a total of 650 mg of aspirin.On the next day, patient was dissolved the filler on the left side and all symptoms resolved immediately.Later, healthcare professional reported 0.3 ml filler in 3 areas of face then had a bluish tinged area 2 of left nostril that extended across the bridge of nose to just past midline cap refill to area l3 sec.Repeated hot compresses and injected 20 unites hylenex (super site) in quadrant where filler was injected l of l nostril in this pattern and then resumed hot compresses to area.Patient was injected with the entire vial of hylenex 150 usp/ml across entire injection area l of l nostril.Resumed hot compress with pinkness had returned to nose and cap refill 1-2 see tenderness per position where hylnex injected and area slightly swollen.Later that night, patient reported their nose is tingly face sore and inflamed but not blue or lacking in color.Symptoms fully resolved on same day.

• 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: 17083934
• Report Number: 3005113652-2023-00440
• Device Sequence Number: 2805732
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: 10/26/2021
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White