MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94493ZQ

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

Patient Problems Cellulitis (1768); Rash (2033); Skin Irritation (2076)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Medical devices continued: with lidocaine.(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of swelling, puffiness, redness, discomfort, hard, lump, cellulitis and mild rash are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: precautions for use - as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials shall be followed.Undesirable effects - the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.Induration or nodules at the injection site.A review of the device history record has been initiated and analysis of the data has not been completed.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the chin line/depression, juvéderm volift with lidocaine in the marionette lines and juvéderm volbella with lidocaine in the upper and lower lips.About 2 months later, the patient had a dental cleaning.Then about 1 month after that the patient was injected with botox.There were no concerns and all good as usual.Around 2 months later, the patient developed hard swollen redness in the chin and lower lip areas.There was some discomfort but no fever.Patient was reviewed by the healthcare professional and prescribed the patient with keflex and prednisone.Patient returned to the clinic 9 days later and they still had hard, swollen and lump interiot lip with slight redness.There was no never or pain.Patient was prescribed ciprofloxacin and metronidazole.Keflex was stopped.It was cellulitis that was suspected 5 months after the injection.Symptoms improved after the 3rd round of antibiotics, but the patient still has a mild rash and swelling/puffiness localized on the chin line.This is the same event and the same patient reported under mdr id #3005113652-2018-01314 (allergan complaint # (b)(4)) and mdr id #3005113652-2018-01315 (allergan complaint # (b)(4)) this is the first mdr submitted for the first suspected product, juvéderm voluma with lidocaine.

Manufacturer Narrative

Corrected data:.

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the chin line/depression, juvéderm volift with lidocaine in the marionette lines and juvéderm volbella with lidocaine in the upper and lower lips.About 2 months later, the patient had a dental cleaning.Then about 1 month after that the patient was injected with botox.There were no concerns and all good as usual.Around 2 months later, the patient developed hard swollen redness in the chin and lower lip areas.There was some discomfort but no fever.Patient was reviewed by the healthcare professional and prescribed the patient with keflex and prednisone.Patient returned to the clinic 9 days later and they still had hard, swollen and lump interiot lip with slight redness.There was no never or pain.Patient was prescribed ciprofloxacin and metronidazole.Keflex was stopped.It was cellulitis that was suspected 5 months after the injection.Symptoms improved after the 3rd round of antibiotics, but the patient still has a mild rash and swelling/puffiness localized on the chin line.This is the same event and the same patient reported under mdr id #3005113652-2018-01314 (allergan complaint # 1702040) and mdr id #3005113652-2018-01315 (allergan complaint # 1702041) this is the first mdr submitted for the first suspected product, juvéderm voluma with lidocaine.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 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: 7970214
• MDR Text Key: 123868027
• Report Number: 3005113652-2018-01313
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 94493ZQ
• Device Lot Number: VB20A70605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVEDERM VOLBELLA WITH LIDOCAINE, JUVEDERM VOLIFT; JUVEDERM VOLBELLA WITH LIDOCAINE, JUVEDERM VOLIFT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR