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

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. ".

• Brand Name: HYALURONIC PEN
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 12634049
• MDR Text Key: 276837615
• Report Number: MW5104624
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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