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

Catalog Number 94155

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Skin Inflammation (2443); Pallor (2468); Vascular System (Circulation), Impaired (2572)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The events of "blanching", "because of the blood pressure behind the occlusion, it burst a vessel and it leaked", and "white heads" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter 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.

Event Description

Healthcare professional reported injecting a patient in the lips with half a syringe of juvéderm® ultra plus xc.The injector reported diluting the filler with.3cc of lidocaine to make it runnier.The injector reported noticed blanching immediately during injection and took the syringe out.The patient was treated with hyaluronidase ¿immediately¿ and ¿because of the blood pressure behind the occlusion, it burst a vessel and it leaked.¿ the patient began using arnica.The patient came back the next day was treated with 10 units of hyaluronidase.It was ¿still blanching¿ and the injector could not tell if it was occluded or bruised¿ and it ¿still looked like there was color in there.¿ the next day, the injector noted that the area was "slightly darker and there were white heads." the patient was given more hyaluronidase.Patient had been taking biotin, omega 3, and multivitamins daily, but stopped taking them a few days before injection.The symptoms have not resolved.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8260268
• MDR Text Key: 133487768
• Report Number: 3005113652-2019-00011
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 94155
• Device Lot Number: H30LA80476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR