MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96183

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Herpes (1898); Vascular System (Circulation), Impaired (2572)

Event Date 01/25/2019

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 reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported 2 days after injection with 0.55 cc of juvéderm volbella® xc in the frown lines (glabella), the patient developed a rash in the scalp (hairline).The following day, the patient noticed bumps and a bruise on the forehead, but felt no pain.The injector treated the event as a vascular occlusion and injected 2-3 vials of hyaluronidase, used nitro paste and aspirin once/day.Patient sent photos 5 days after injection showing a scab that was ¿yellowish.¿ that is when injector diagnosed this as shingles and prescribed a medrol dosepak.All symptoms resolved within a few days.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8410378
• MDR Text Key: 138513026
• Report Number: 3005113652-2019-00207
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Catalogue Number: 96183
• Device Lot Number: V15LA80469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR