MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96181

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Subcutaneous Nodule (4548)

Event Date 01/15/2021

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.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

Patient reported that they were injected with juvéderm® volbella¿ with lidocaine in lines above top lip.Thirteen months later, patient was injected again in lines above top lip with juvéderm® volbella¿ with lidocaine.Approximately three weeks later, patient developed granulomas on both sides of mouth and bruising.Patient was treated with steroid shots, hyaluronidase, antibiotics, and oral steroids.Two months after the injection, the granulomas were surgically removed, and patient developed scar and lack of feeling in nose and lip area.Patient will be treated again with hyaluronidase.Patient is on antidepressants and blood pressure medication.Patient has history of botox®.No additional information was provided.

Manufacturer Narrative

Corrected data: b.3., g.1.

Event Description

Patient reported that they were injected with juvéderm® volbella¿ with lidocaine in lines above top lip.Thirteen months later, patient was injected again in lines above top lip with juvéderm® volbella¿ with lidocaine.Approximately three weeks later, patient developed granulomas on both sides of mouth and bruising.Patient was treated with steroid shots, hyaluronidase, antibiotics, and oral steroids.Two months after the injection, the granulomas were surgically removed, and patient developed scar and lack of feeling in nose and lip area.Patient will be treated again with hyaluronidase.Patient is on antidepressants and blood pressure medication.Patient has history of botox®.No additional information was provided.

Manufacturer Narrative

Clarification to h6: 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.The event of granuloma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

Event Description

Healthcare professional reported patient was injected with 0.7ml juvéderm® volbella¿ with lidocaine and fourteen months later, patient was injected with the remaining 0.3 ml juvéderm® volbella¿ with lidocaine.Patient was concomitantly injected with 4u botox® in upper lip during the first injection.One month later, patient received zoster vaccine shingrix®.Approximately one month later, patient tested positive for covid-19.Nine months later, symptoms developed.Two months later, patient's salivary gland was biopsied by another healthcare professional (hcp).One month later, needle aspiration was performed by another hcp.Patient also received the first dose of unspecified covid-19 vaccine.One month later, a needle biopsy was performed by another hcp.One month later, a left medial mala excision was performed and found consistent with dermal filler reaction.Patient was treated with kenalog® 5mg injection in granulomas, moxifloxacin 400mg, and prednisone 50mg.The granulomas was surgically removed via l medial mala excision.Patient was treated again with the same antibiotics and steroids the next month.The patient was treated with hyaluronidase for the next two months, once per month and again in three months.Patient has scar from incision and the granulomas are recurring.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12249373
• MDR Text Key: 265174436
• Report Number: 3005113652-2021-03123
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Catalogue Number: 96181
• Device Lot Number: V15LA90416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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
• Treatment: ANTIDEPRESSANTS AND BLOOD PRESSURE MEDS; VENLAFAXINE HCL ER 37.5MG, NAPROXEN, BOTOX®
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG