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U.S. Department of Health and Human Services

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

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HYALURON IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameHYALURON
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
MDR Report Key10051422
MDR Text Key191011615
Report NumberMW5094473
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2020 Patient Sequence Number: 1
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