MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLIFT

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

Patient Problem Cytomegalovirus (CMV) Infection (2220)

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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of herpes simplex, deemed not related to the injections, is considered an unexpected adverse drug experience.

Event Description

Healthcare professional (hcp) reported a patient was injected with juvéderm® voluma¿ in ck2 and juvederm® volift® xc in lower lips.Three days later, patient developed herpes infection in the lips, deemed not related to the injections.About five to seven days later, patient developed an inflammatory infiltrate in the lower lip area.Patient was treated with high-dose valtrex along with prednisolone.The infiltrate and herpes sore improved considerably and disappeared completely after 5-7 days later.This is the same event and the same patient reported under mdr id# 3005113652-2021-00265 (allergan complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvederm® volift® xc.

• Brand Name: VOLIFT (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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 11966741
• MDR Text Key: 265562560
• Report Number: 3005113652-2021-00266
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLIFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention