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

Catalog Number 94154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: topical lidocaine in perioral area.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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 Description

Healthcare professional reported injecting 1 ml of juvederm® ultra in the patient's lips.The patient was concomitantly given 2%lido/nabicarb in the periform aperture and topical lidocaine in the perioral area.24 hours later the patient began experiencing "shortness of breath." two days later the patient went to the er for "swelling in the lips, pain, and shortness of breath." patient was prescribed prednisone, 10 mg (4 pills for 4 days), for the symptoms.The filler was dissolved but swelling / pain have not been resolved.

Manufacturer Narrative

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.

Event Description

Additional information clarified that the filler was not dissolved, but the symptoms have resolved.

• Brand Name: JUVEDERM ULTRA 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
• MDR Report Key: 12212162
• MDR Text Key: 262972148
• Report Number: 3005113652-2021-03102
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB10001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2%LIDO/NABICARB IN THE PERIFORM APERTURE; 2%LIDO/NABICARB IN THE PERIFORM APERTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR