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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HYALURONIC PEN ACID, HYALURONIC, INTRAARTICULAR

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HYALURONIC PEN ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/03/2021
Event Type  Injury  
Event Description
I got hyaloron fillers injected at (b)(6) day spa and it's owner located at (b)(6) she also gave me a lymphatic drainage massage and i found out she's only ever been a dental assistant she also does illegal braces in this place unlisted. "were hurt or a bad side effect (including new or worsening symptoms. ".
 
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Brand NameHYALURONIC PEN
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key12634049
MDR Text Key276837615
Report NumberMW5104624
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
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: 10/13/2021 Patient Sequence Number: 1
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