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

Catalog Number 96183

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

Patient Problem Unspecified Infection (1930)

Event Date 11/15/2020

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 discarded. 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 reported a patient was injected with 2 syringes of juvéderm voluma® xc in the cheeks, 2 syringes of juvéderm® ultra plus xc in the marionette lines and oral commissures, and 1 syringe of juvéderm volbella® xc in the upper lip and lines around the upper lip. Two weeks later, patient came back and was injected with 1 syringe of juvéderm volbella® xc in the lower lip. Approximately less than 2 months later, patient reported they experienced bumps, hard subcutaneous nodules above the upper lip, 1 bump under their right eye in the medial cheek, and 1 bump in the lower lips. Patient also stated they had a cold (deemed not related to the device) the week before. Healthcare professional believed patient had experienced biofilm, without a biopsy to confirm. Per physician, the biofilm might be caused by "a cold virus. " a cbc test was performed and came back with slightly elevated neutrophils. Patient was treated with a steroid injection of triamcinolone, prescribed a methylprednisolone dose pack, and prescribed clarithromycin. Event is ongoing. This is the same event and the same patient reported under mdr id # 3005113652-2020-00790 (allergan complaint # (b)(4)), mdr id # 3005113652-2020-00791 (allergan complaint # (b)(4)), and mdr id # 3005113652-2020-00793 (allergan complaint # (b)(4)). This mdr is submitted for the third suspect product, juvéderm volbella® xc.

• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 11043654
• Report Number: 3005113652-2020-00792
• 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
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/10/2020
• Device Catalogue Number: 96183
• Device Lot Number: V15LA80692
• 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(s): "A LOT OF VITAMINS"
• Patient Outcome(s): Required Intervention