MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA/24HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Herpes (1898); Pain (1994); Vascular System (Circulation), Impaired (2572)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.These are known potential adverse events addressed in the product labeling.The events of pain, occlusion, and "mouth ulcerations" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Healthcare professional reported injecting a patient in the lip with an unspecified amount of juvéderm® ultra.The patient reported back to the injector 2 days later with ¿pain and an occlusion.¿ that same day, they treated the patient with an aspirin, nitro paste, hylenex, and compresses for 5 hours.Four days later, the patient was getting ¿mouth ulcerations and the patient came in to get the same treatment and platelet-rich plasma.The patient improved and was no longer in pain.The injector reported using an insulin syringe and believes it may have been the problem.

• Brand Name: JUVEDERM ULTRA/24HV (VOLUME UNKNOWN)
• 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: 8237335
• MDR Text Key: 132781173
• Report Number: 3005113652-2019-00015
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR