MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA W/LIDO 2X1ML EAME SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96658JR

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

Patient Problems Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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. 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 injected with 1 ml of juvéderm® volbella¿ with lidocaine in the dark circles. Injection site confirmed to be "asepsis" prior to injection. During injection, tyndall effect and granulomas formed that did not improve with manual massage. No report of biopsy of granulomas to confirm. The next morning, patient presented with edema at the injection site with granulomas and tyndall effect persists. The surrounding area was swollen and bluish. Event ongoing.

• Brand Name: JUVEDERM VOLBELLA W/LIDO 2X1ML EAME SKU1
• 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 ; 7372473605
• MDR Report Key: 11078107
• MDR Text Key: 223800117
• Report Number: 3005113652-2020-00815
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 96658JR
• Device Lot Number: V15LB00070
• 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: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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: 12/28/2020 Patient Sequence Number: 1