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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Skin Irritation (2076)

Event Date 09/17/2019

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.This is a known potential adverse event addressed in the product labeling.This medwatch is in response to fda report number mw5091146.Allergan is unable to confirm with the healthcare professional; therefore, additional event, product, or patient details are not attainable.

Event Description

Received regulatory report where a patient was injected by another injector in the nasolabial and perioral area with juvéderm voluma® xc.A year later, the patient developed ¿a firm subcutaneous mass in the right nasolabial fold region¿.A ct scan and mri were performed that showed ¿an area of ill-defined tissue prominence in the right facial subcutaneous tissues favoring an infection/inflammatory process within 2 months of the first nodule appearing.¿ several additional subcutaneous nodules developed 2 x 2.5 cm nodule in right nasolabial fold, 1 x 1 cm nodule in left nasolabial fold, and 5 subcentimeter perioral nodules.The patient was treated with hyaluronidase and kenalog 20 with slight decrease in size of the nodules.No other information was provided.

• 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 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 9530531
• MDR Text Key: 173305402
• Report Number: 3005113652-2019-00881
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention