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

Catalog Number 94728JR

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

Patient Problems Foreign Body Reaction (1868); Necrosis (1971)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

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.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.These are known potential adverse events addressed in the product labeling.

Event Description

Healthcare professional (hcp) reported injecting a patient with juvéderm® voluma¿ with lidocaine and juvéderm® volbella¿ with lidocaine.The injector received a biopsy report, dated about 10 months after the injection, from the treating hcp showing a diagnosis of ¿extensive granulomatous inflammation aimed at foreign material of uncertain nature.¿ patient presented bilateral nodular lesions in the area of the prefacial lymph nodes, cheeks.Clinically necrosis was seen.Patient recovered fully with no visual lumps on skin.Patient is comfortable with the outcome.This is the same event and the same patient reported under mdr id # 3005113652-2020-00339 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volbella¿ with lidocaine, also a device manufactured by allergan.

• 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: 10167976
• MDR Text Key: 195571781
• Report Number: 3005113652-2020-00340
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: SF
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA80602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA¿ WITH LIDOCAINE
• Patient Age: 57 YR