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 Problems Cytomegalovirus (CMV) Infection (2220); Respiratory Tract Infection (2420)

Event Date 01/01/2021

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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Clarification: the event of (b)(6) is a known potential adverse event addressed in the product labeling.The event of sinusitis (not device related) is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported that patient was injected with juv¿derm¿ volbella" with lidocaine in barcode region above lip.Eleven months later, patient was injected with juv¿derm¿ volbella" with lidocaine in barcode region above lip.Patient developed left side erythema in upper lip and "edema on filter and left side line.Patient was prescribed rizzi for 10 days and topison.Approximately four years later, patient developed sinusitis (deemed not related to the device) and was treated with antibiotics for 7 days, as well as anti-allergy, steroids, and would undergo a tomography because of the unresolved sinusitis.Approximately three weeks later, patient developed lumps in injection area and "intense edema" that was recurring as well as a (b)(6) lesion with pain, mild erythema, and hardness in the area.Patient was treated with (b)(6) for 4 days.Approximately three weeks later, patient received astrazeneca covid-19 vaccine.Persistent symptoms treated with predsim 20mg/day, 5 days; altiva 180, 10 days.Two weeks later, edema had reduced, erythema was still present with nodules and itching.Patient was treated with anti-allergic and topical corticosteroids.This is the same event and the same patient reported under mdr id# 3005113652-2021-03171 (allergan complaint # (b)(4)).This mdr is being submitted for the first suspect product, juv¿derm¿ volbella" with lidocaine.

• 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
• 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: 12337533
• MDR Text Key: 267105864
• Report Number: 3005113652-2021-03172
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ESCITALOPRAM, T4
• Patient Outcome(s): Required Intervention