MAUDE Adverse Event Report: ALLERGAN JUVEDERM; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Stroke/CVA (1770); Chest Pain (1776); Fall (1848); Necrosis (1971); Dizziness (2194)

Event Date 03/29/2019

Event Type  Injury  

Event Description

I had 1 syringe of juverderm into the chin and 1 syringe of kybella under the chin.Within the first 24-48 hours i developed cellulitis, then during days 1-10 my skin on my head and neck and face started peeling excessively, the kybella mixed with juverderm ate through several layers of skin, days 1-30 i had severe chest pain, blue bulging veins appearing on chest, trouble breathing, skin necrosis around the area where juvederm was injected.Also now day 50 the area that was injected with kybella is working aggressively on me, dissolving too much fat, it is even moving up into my lower face and eating away at my facial fat.My skin is dying and dying every day.My head pops when i turn it right or left.I am dizzy every day, falling over, the kybella ate through my platysma bands and got into my arteries.The juvederm is stuck in an artery and i have had 3 mini strokes.There is a very adverse reaction with getting juvederm and kybella in the same day right near each other.I am hospitalized, suffered multiple strokes and my face is being melted away.It's now day 50 and the kybella will not stop eating away at me, my jaw bone is now appearing from under the skin.It is now melting my jaw bone too.

• Brand Name: JUVEDERM
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8627827
• MDR Text Key: 145845755
• Report Number: MW5086786
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 40 YR
• Patient Weight: 54