MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

Device Problem Off-Label Use (1494)

Patient Problem Nodule (4551)

Event Date 01/15/2022

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 discarded.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient in the tear trough with 1 ml of juvéderm® voluma¿ xc.A year later, the patient received their first covid-19 vaccines and the second one a month later.A month after the 2nd vaccine, the patient was injected in the lips with 1 syringe of juvéderm® volbella¿ xc and in the cheeks with 2 syringes of juvéderm® voluma¿ xc.Approximately two months later, the patient experienced ¿swelling, induration and nodules," "latent hypersensitivity reaction," "red, swollen nodules noted under in right tear trough" and "hard to the touch and swollen" lips.The patient self-treated with benadryl.Two months later, the patient visited the office and was given a tapered steroid dose, 3 (20 mg) tabs for 2 days, 2 (20 mg) tabs for 2 days, and 1 (20 mg) tab for 3 days.When treatment ended, the event resumed.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00182 (allergan complaint # (b)(4)) and mdr id# 3005113652-2022-00183 (allergan complaint # (b)(4)).This mdr is being submitted for the first injection of suspect product, juvéderm® voluma¿ xc.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
• 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: 13931306
• MDR Text Key: 291239221
• Report Number: 3005113652-2022-00181
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female