MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

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

Patient Problems Asthma (1726); Bronchitis (1752); Pneumonia (2011)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been completed.No deviations or non-conformances noted.The events of "asthma, bronchitis and pneumonia" are deemed not device related but are considered unexpected adverse drug experiences.

Event Description

Healthcare professional reported a patient was injected with 1.0 cc of juvéderm voluma® xc and 1.0 cc of juvéderm volbella® xc in the cheeks and nasolabial.Five months later, patient was injected with 1.0 cc juvéderm voluma® xc in the cheeks.Seven months later, patient was injected with 1.0 cc juvéderm® ultra plus xc in cheeks.Approximately seven months later, patient developed asthma, pneumonia, and bronchitis and was given prednisone on a tapering regiment for 6 months, deemed not related to the device.Three months later, patient was injected with 1.0 cc juvéderm voluma® xc in the checks and 1.0 cc juvéderm volbella® xc in the infraorbital hollow.Three months later, patient developed firmness throughout the cheeks and watery edema in the malar bag region.Patient was treated with doxycycline and hylenex® was administered to remove some product from the cheeks ¿ this improved the edema slightly.Patient has weekly assessments at clinic and is also taking singulair®.Patient is taking alternating doses of 2 and 4mg prednisone od.It was also noted that patient had restylane on an unknown date and have had other unknown fillers in the past six years.Symptoms are improving but ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-00046 (allergan complaint #(b)(4)), mdr id# 3005113652-2021-00046 (allergan complaint #(b)(4)), and mdr id# 3005113652-2021-00041 (allergan complaint #(b)(4)).This mdr is being submitted for the third suspect product, juvéderm voluma® xc.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX ; 7372473605
• MDR Report Key: 11273762
• MDR Text Key: 230096451
• Report Number: 3005113652-2021-00026
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR