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

Device Problem Product Quality Problem (1506)

Patient Problems Bruise/Contusion (1754); Swelling (2091); Reaction (2414)

Event Date 02/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 i went to a lip filler appointment with permanent makeup artist (b)(6).She injected the filler using a device called the hyaluron pen that i eventually found out is not fda-approved and it ended up causing immediate trauma to my lip.She hit a blood vessel and my lip swelled to the size of a grape within 10 minutes, and also turned black.At that point i began to panic and after doing some quick (b)(6), rushed to the emergency room to get my lip examined by a licensed doctor.After spending 6 hours in the er i eventually had the hyaluronic acid dissolved by a licensed plastic surgeon.I hope that by sending this report and providing photo proof, no one else will have to go through the same experience i had with (b)(6).(b)(6) tried to assure me that amount of bruising was normal, and that i had nothing to worry about.After voicing my concerns about the size of the bruise and sending her updated pictures 30 minutes after the procedure, she tried to send me away to another (b)(6) or the er to get it dissolved professionally because she did not have a license to do so herself.

• Brand Name: HYALURON
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• MDR Report Key: 10051422
• MDR Text Key: 191011615
• Report Number: MW5094473
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 56