MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96183

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

Patient Problem Dyspnea (1816)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional reported injecting a patient in the lips with half a syringe of juvéderm volbella® xc.A few hours later, the patient experienced ¿extreme swelling¿ on the tip lip, nose, and lower face.The patient was treated with kenalog and antibiotic.Later, the patient had extreme swelling of the entire face and was admitted to the hospital due to "respiratory distress" and was given iv solumedrol and epinephrine.The event resolved approximately 72 hours after onset.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Type of Device: 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12310488
• MDR Text Key: 266166945
• Report Number: 3005113652-2021-03140
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• 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: 08/11/2021

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: 09/30/2022
• Device Catalogue Number: 96183
• Device Lot Number: V15LB00884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR