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

Catalog Number 94201JR

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

Patient Problems Abscess (1690); Inflammation (1932); Skin Irritation (2076)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. 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. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional reported injecting a patient in the cheeks with juvéderm® volift¿ and jaw with juvéderm® volux¿. Approximately a month later, patient experienced ¿lumps¿ in the lips, ¿pus extruded¿ and there was an ¿inflammatory reaction¿ with abscess mouth / jaw. Patient was treated with clarithromycin and clindamycin. Event ongoing.

• Brand Name: VOLIFT 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: 10971620
• MDR Text Key: 220465371
• Report Number: 3005113652-2020-00733
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 94201JR
• Device Lot Number: V17LA90395
• 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: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/08/2020 Patient Sequence Number: 1