MAUDE Adverse Event Report: ALLERGAN VOLUMA DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number VB20A90383 12/2

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

Patient Problems Fever (1858); Nausea (1970); Malaise (2359)

Event Date 10/31/2019

Event Type  Injury  

Event Description

Patient developed nodules one month s/p dermal filler in the cheeks.The nodules were precipitated by a flu-like virus.Patient being treated with hylenex amd antibiotics.Patient reports fever, body aches and nausea in the day to 2 days preceding the nodules.Dermal filler for facial volume loss.

• Brand Name: VOLUMA DERMAL FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 9291048
• MDR Text Key: 165956023
• Report Number: MW5090936
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/01/2022
• Device Lot Number: VB20A90383 12/2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1