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 Problem Granuloma (1876)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 discarded.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a patient was injected with in the cheeks with 1cc of juvéderm voluma® xc.Sixteen months later, the patient was injected in the cheeks with 1cc of juvéderm voluma® xc.A year later, the patient was injected in the nasolabial folds and marionette lines with 1cc of juvéderm® ultra plus xc.Three months later, the patient was injected in the upper lip with 0.5cc of juvéderm volbella® xc.About two years later the patient was injected in the cheeks with 1cc of juvéderm voluma® xc.Approximately 11 months later, the patient experienced ¿swelling¿ of the right cheek and ¿moderate edema¿ of nasolabial fold region that ¿appears to have fluid collection¿ at nasolabial fold.The patient was treated with io injection, ant max buccal vest incision and i+d of region.Fully drained, irrigated, start augmentin with warm compresses and saline rinses.Three days later, ¿gross pus¿ was present, and another incision and drainage were performed along with bactrim and a warm compress.A week later, patient was admitted to the hospital treatment of i+d, iv antibiotics (abx).Patient was put on augmentin/cipro.11 days later, it was noted right cheek, nl fold essentially back to normal and soft.There is a trace of residual erythema but no infection, no drainage, and healed right cheek abscess.Ten months later, the patient experienced ¿mild right nasolabial fold hyperemia¿ and was started on antibiotics.The hyperemia resolved half a month later.Six and a half months later, the patient experienced ¿mild edema on the left nasolabial fold and was given ice.A month later, the patient experienced inflammation and was started on a medrol dosepak.A month later and symptom has not been resolved, patient was treated with augmentin, hyaluronidase to left and right nl regions, and antihistamines.The next month, enlarged and painful left nl fold, some nodularity and fluid.Right with lower nodularity.Patient was treated io incisions with blunt dxn, copious granular fluid and granular drainage b/i.Nss washout.Smm stab incisions left open, local care with ice to cheeks.Patient was put on bactrim and peridex, hydrocodone/valium and gentle massage and event resolved.The following month, patient experienced left cheek with moderate fluid collection but does not appear to be infection but persistant inflammation/fluid production.Patient treated with i+o, i+d performed with 5cc of pus drained and continue current care and event resolved within the month.Two months later, patient experienced mild edema with small non-tender nodule in upper lip.The next month, patient was treated with i+d on left upper lip lesion.3mm incision on lip, blunt dissection and debridement, washout and single suture placed.Patient was put on bactrim.Two months later, patient was treated with punch bx of resion, washout and fine hemostate exporation with some thick granular areas.Oral abx prescribed.Sent lesion to pathology (biopsy performed).Biopsy of upper left lip resulted noted "hyaluronic acid material with granulomatous foreign body reaction.The events are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00165 (allergan complaint # (b)(4)), mdr id# 3005113652-2022-00167 (allergan complaint # (b)(4)), mdr id# 3005113652-2022-00168 (allergan complaint # (b)(4)), and mdr id# 3005113652-2022-00169 (allergan complaint # (b)(4)).This mdr is being submitted for the fourth of the suspect product, juvéderm volbella® xc.

• 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
• 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: 13929319
• MDR Text Key: 288038431
• Report Number: 3005113652-2022-00170
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 03/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female