MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

Device Problem Off-Label Use (1494)

Patient Problem Skin Irritation (2076)

Event Date 10/07/2020

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 not returned for evaluation.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 reports patient injection with 1 syringe juvéderm vollure¿ xc in the ¿lips and nasolabial folds.¿ patient was "ok" 2, 4 and 5 weeks after injection.7.5 weeks after injection, patient's lips were ¿hard as a rock.¿ the injector dissolved their lips with hyaluronidase on day of symptom onset, again 5 days later and a last dose 2 weeks later.Symptoms are ongoing.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Approximately three and a half months post symptom onset, symptom resolved.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 10962634
• MDR Text Key: 220144533
• Report Number: 3005113652-2020-00758
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Catalogue Number: 95661
• Device Lot Number: V17LB00418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR