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 11/04/2020

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 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 of juvéderm vollure¿ xc in the lips. Patient was "ok" 2, 4 and 5 weeks after injection. 7 weeks after injection, patient's lips were ¿hard as a rock. ¿ the injector treated patient with hylenex on day of symptom onset. Symptoms are ongoing.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10962732
• MDR Text Key: 220154831
• Report Number: 3005113652-2020-00757
• 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,health

Reporter Occupation

• 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

• Device Expiration Date: 05/16/2022
• Device Catalogue Number: 95661
• Device Lot Number: V17LB00418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/07/2020 Patient Sequence Number: 1