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

Catalog Number UNK VOLBELLA

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

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

Event Date 02/15/2020

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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that patient was injected with juvederm® volift¿ with lidocaine, hydrate, and juvederm® volbella¿ with lidocaine were injected in temporal, malar, cheek support, nasojugal and nasogenian grooves.Approximately 7 months later, patient was injected with volbella¿ with lidocaine in lower lip body, nasogenian groove and marionette lines and botox® treatment.Approximately 6 months later, patient was injected with juvederm® volift¿ in lips outline.Approximately 11 months later, patient was injected with volbella¿ with lidocaine in the dark circles and lips outline.Five months later, patient had botox® treatment.Six months later, patient was injected with juvederm® volbella¿ with lidocaine in dark circles and lip outline.Two months later, patient was injected with juvederm® volbella¿ with lidocaine in nasogenian groove and marionette bars.Approximately 11 months later, patient was injected with juvederm® voluma¿ with lidocaine in cheek.Approximately 2 months later, patient was injected with juvederm® volbella¿ with lidocaine in lips in superior nasogenian groove, lips and marionette bars with juvederm ® volite¿ in the periocular.Approximately a year later, patient was injected with juvederm® volbella¿ with lidocaine in nasogenian groove and marionette bars with juvéderm® voluma¿ with lidocaine and two different kinds of non allergan devices were injected in dark circle areas and jaw angle.Approximately 4 months later, patient experienced developed facial edema on the cheeks, perocular, and oral mucosa, more so on the lips.Eight months later, patient was treated with intramuscular betamethasone.Four days later, patient then prescribed 3-day medrol dose pack.Eleven days later, patient had ultrasound that showed granulomas in nasolabial region (not confirmed by biopsy), edema with hypoechoic fluid bundles in malar region, fibrous scar tissue, and superficial phlebitis of the vein.On the same day, patient was treated with 750u of hyaluronidase.Five days later, patient was treated with kenacort and given clarithromycin prescription.Symptoms are partially solved.This is the same event and the same patient reported under mdr id # 3005113652-2020-00725 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00726 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00727 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00728 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00730 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00765 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00723 (allergan complaint #(b)(4)), and mdr id # 3005113652-2020-00724 (allergan complaint #(b)(4)).This mdr is being submitted for the 6th suspect product, juvederm® volbella¿ with lidocaine.

• Brand Name: UNK VOLBELLA
• 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: 10960572
• MDR Text Key: 219985603
• Report Number: 3005113652-2020-00729
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 45 YR