MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96181

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

Patient Problem Viral Infection (2248)

Event Date 09/23/2020

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.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 not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.The event of infection - ndr is considered an unexpected adverse drug experience.

Event Description

Health professional reported injecting a patient in the lip/perioral area with 1 ml of juvéderm volbella® xc.Three months later, the patient was prepped on the lower side for a dental crown.A week later, the patient reported experiencing ¿hard and tender bumps¿ but no swelling.A week and a half later, the patient started a "doxi antibiotic." four days later, the patient went back to the dentist and was given novocain and had the crown set on right side.For the following 5 days, the patient¿s lips were very swollen, especially the upper right side.Two days later, the patient was treated with hylenex and prescribed prednisone for 3 days.The patient returned 6 days later for more hylenex.The health professional later reported that the patient was going to be managed by them in the clinic but "got covid." the patient has since recovered from covid but the injector later contracted covid and was not able to see the patient.The event is ongoing.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10968126
• MDR Text Key: 220216309
• Report Number: 3005113652-2020-00734
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: 96181
• Device Lot Number: V15LA90358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1