MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151EC

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

Patient Problem Depression (2361)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient representative reported that the patient was injected in the mouth and dark circles with juvéderm ultra¿ xc, in the dark circles with non-allergan product princess® filler lidocaine, and in the chin with juvéderm® voluma¿ with lidocaine.The day after the procedure, the patient experienced swelling with highly visible bruises and a lot of pain in the region below the eyes, where the procedure with hyaluronic acid was performed.The patient was very distressed with the deformity on the face.Allegedly, the injector stated that such sequelae would disappear within 30 days.Noticing a progressive worsening in patient¿s face, the patient went to an appointment with a dermatologist 8 days after the day of onset.The doctor prescribed prednisone 20mg and informed the patient that due to being unaware of the product used, ¿the diagnosis was tp open and the treatment could only be palliative.After 30 days elapsed, ¿the deadline for consolidation of said treatment, the bruises and swelling in the region of patient¿s eyes did not diminish and lumps on the face appeared.In addition to the aesthetic dissatisfaction, patient mentioned the risks of necrosis and blindness.¿ allegedly, the injector argued ¿that patient is extremely allergic¿.However, the patient has history of ¿the same product - hyaluronic acid - obtaining a satisfactory result at the time and without any allergic reactions.¿ ¿in the other injected locations (eyes, chin and mouth), although there was little swelling or bruising, the proposed result was not achieved, first due to the mistaken use of product density, second due to the inadvertent use of hyaluronic acid in the region of dark circles, under the terms of the medical report / budget presented, causing deformity on the face¿.¿the procedure was carried out in a hair salon, in a detached room for performing aesthetic treatments, with no indication of permits and licenses required for the practice of the performed aesthetic activity.¿ allegedly, the dermatologist informed that ¿filling in the dark circles region presents bulging in the infra-eyelid location¿.Allegedly, a dental surgeon informed the following: "there is an excess of filler in the region of the dark circles, hyaluronic acid, the treatment being indicated at the moment, the application of hyaluronidase to remove the material, and subsequent reassessment of the need for further filling".Allegedly, the report of another plastic surgeon contained: ¿diagnosis: bulging in the region of the eyelid - malar groove due to inadvertent accumulation of substances in the subcutaneous plane.Conduct: correction of deformity with non-surgical treatment.Proposed treatment: 1) chemical elimination of bulging bilateral malar eyelid; 2) restructuring of the malar region with high density hyaluronic acid; 3) filling the malar eyelid groove with medium density hyaluronic acid¿.The patient stayed for more than 60 (sixty) days with swelling and bruising on [the] face, being able to undergo corrective treatment to remedy the problems on [the] face only in [the third month after the date of onset].¿ physician¿s notes noted ¿bilateral bulgingly at the infrapalpebral site¿ and ¿[regarding the adverse event,] patient has developed a moderate depressive episode associated with stress.¿ the status of the event is unknown.This is the same event and the same patient reported under mdr id # 3005113652-2020-00290 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® voluma¿ with lidocaine, also a device manufactured by allergan.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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: 10116774
• MDR Text Key: 194007058
• Report Number: 3005113652-2020-00291
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A80545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR