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

Catalog Number 96637JT

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

Patient Problems Inflammation (1932); Skin Irritation (2076)

Event Date 10/15/2020

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 (hcp) reported patient was injected in the chin area with 1. 4 ml juvéderm® volux¿ and 1. 0 ml juvéderm® voluma¿ with lidocaine. 1 month after the treatment, the patient complained about redness, pain, odema on chin area. Patient denied any systemic symptoms. Patient was prescribed a course of oral antibiotics (amoxicillin and clavulanic acid). On check up, symptoms persisted and the filler on chin area was removed with small incision and drainage, and rest of the filler was dissolved with hylauronise injection. Hcp states, based on "clinical signs of symptoms, and during the surgical intervention that was performed, that the complication that occurred was formation of foreign body granuloma". No biopsy report to confirm. The patient is now feeling well, without any signs and symptoms, and without any consequence. Symptoms resolved 1 month post onset.

• Brand Name: JUVEDERM VOLUMA 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 11041526
• MDR Text Key: 222631666
• Report Number: 3005113652-2020-00756
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: RB
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 96637JT
• Device Lot Number: VB20A90789
• 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: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/18/2020 Patient Sequence Number: 1