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

Catalog Number UNK VOLBELLA

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

Patient Problem Cytomegalovirus (CMV) Infection (2220)

Event Date 09/15/2021

Event Type  Injury  

Event Description

Healthcare professional reported that juvederm vista volbella xc was injected in the lips two weeks after covid-19 vaccination. One week later, "swelling presented on lips and antibiotic/hyaluronidase was treated. After that herpes was observed. ".

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The event of herpes simplex is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.

• Brand Name: UNK VOLBELLA
• 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: 12611479
• MDR Text Key: 281279584
• Report Number: 3005113652-2021-03318
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No