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 Edema (1820); Skin Irritation (2076)

Event Date 02/04/2020

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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported to company representative that a patient experienced ¿intermittent edema on the right side of the face lateral to the tear trough" and "nodule" after they were injected in the temples and midface with juvéderm voluma® xc.Treatment is noted as ¿doxycycline 100mg bid x14 days¿, ¿hyaluronidase 0.5cc¿, ¿hyaluronidase 1.0cc¿, ¿doxycycline 100mg bid x14 days¿, and ¿hyaluronidase 1.0cc." patient also received prednisone 10 mg.It was noted patient noticed edema after flight travel and a relapse after second flight and is presently under observation.Event is ongoing at this tine.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, corrected, and/or changed data: h.6.

Event Description

Healthcare professional reported to company representative that a patient experienced ¿intermittent edema on the right side of the face lateral to the tear trough" and "nodule" after they were injected in the temples and midface with juvéderm voluma® xc.Treatment is noted as ¿doxycycline 100mg bid x14 days¿, ¿hyaluronidase 0.5cc¿, ¿hyaluronidase 1.0cc¿, ¿doxycycline 100mg bid x14 days¿, and ¿hyaluronidase 1.0cc." patient also received prednisone 10 mg.It was noted patient noticed edema after flight travel and a relapse after second flight and is presently under observation.Event is ongoing at this tine.

• 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 74370 ; FR 74370
• MDR Report Key: 10468831
• MDR Text Key: 204871796
• Report Number: 3005113652-2020-00495
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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: 02/20/2021
• Device Catalogue Number: 94640
• Device Lot Number: VB20A90458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR