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

Catalog Number 94728ZQ

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

Patient Problem Pneumonia (2011)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of not device related "pneumonia" is considered an unexpected adverse drug experience.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 pneumonia is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional reported injecting a with 1 cc (0.5 cc per side) of juvéderm¿ voluma¿ with lidocaine on the cheek bone / zygomatic area.2 weeks later patient was injected in the lips with from juvéderm® volbella® with lidocaine.2 months later the patient was hospitalized and was diagnosed with pneumonia 2 days after being hospitalized; deemed not related to the device.On that same day the patient was treated with antibiotics for the pneumonia.About 2 months and 2 weeks later, patient noticed that the right side cheek was slightly tender and hard and a bit painful to touch.Patient visited the er where patient was sent home with keflex® 500mg for 7 days.Injector assessed the patient 3 days after the event was noticed ¿and the area of concern (right upper cheek) looked slightly puffy.When palpated the area didn't appear hard anymore, also [patient] did not have any pain or tenderness in that area.¿ injector ¿is not sure if it is possible for [the patient] to develop inflammatory nodules as a result of [the] pneumonia?¿.Patient was advised to start on the antibiotics that the er gave them and followed up with the patient during the weekend of that week.The patient was showing symptoms of discomfort.The facility's physician was consulted on the same day, ¿who advised the patient to take 2 [advil®] and [benedryl®] 50mg every 4 hours for a few days.¿ patient visited the physician 5 days later.Physician said it¿s ¿a late reaction to filler.¿ physician gave the patient ¿stronger anti inflammatory naproxen 275mg to be taken every 6 hours and told [the patient] to put ice packs and to consider hyaluronidase in small injections.¿ ½ ml of hyaluronidase was used 4 days later under right eye to dissolve the filler that has hardened.Patient returned 2 weeks later for follow up and they felt the hardening of the filler under the left eye too and it was uncomfortable too but not as bad as the right eye.This was also described as ¿hard nodule¿ on the other cheek as well.In addition, patient had three solid hard and painful nodules above the upper lip from juvéderm® volbella® with lidocaine.These were dissolved too.The event is ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2020-00747 (allergan complaint # (b)(4)).This is the second mdr submitted for the second suspect product, juvéderm® volbella® with lidocaine.

Event Description

Additionally, healthcare professional reported that the volume injected of juvéderm® volbella® with lidocaine was 1 ml.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional, corrected, and/or changed data: a4, b5, h6, h8.

• 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
• MDR Report Key: 11023444
• MDR Text Key: 222009383
• Report Number: 3005113652-2020-00799
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 94728ZQ
• Device Lot Number: V15LA90140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 130