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 Inflammation (1932); Skin Irritation (2076)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that a patient was injected with juvéderm¿ voluma¿ with lidocaine.The patient experienced swelling in the chin where the product was injected.The hcp saw the patient a year later; patient has ¿swelling, redness and hard nodules.¿ the event is ongoing.

Event Description

Healthcare professional reported that a patient was injected with 3 ml of juvéderm¿ voluma¿ with lidocaine (1 ml per cheek and 1 ml in the chin).The patient experienced swelling in the middle and left side of the chin, injection site.The hcp saw the patient about a year later; patient had ¿swelling, redness and hard nodules.¿ ¿felt unwell a few days prior [maybe 2-3 days], could have been triggered by a fl[u] like illness¿.¿the main thing is that the unwell feeling ? flu like symptoms preceded the lumps.At which point [patient] came to see [the physician]¿.Patient was started on antibiotics for 10 days on the reported date of onset.The patient did not wish any other interventions or to dissolve the product.Patient was happy with the outcome.The symptoms resolved 3 days later with no further investigation after the antibiotics.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Clarification to section h6: the filler was injected into the patient and is not accessible for return.The syringe was discarded.

• 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: 11015592
• MDR Text Key: 221737902
• Report Number: 3005113652-2020-00744
• Device Sequence Number: 1
• Product Code: LMH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 12/31/2020
• Device Catalogue Number: 94493ZQ
• Device Lot Number: VB20A90057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR