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

Device Problem Product Quality Problem (1506)

Patient Problems Bruise/Contusion (1754); Rash (2033); Swelling (2091); Reaction (2414)

Event Date 01/17/2020

Event Type  Injury  

Event Description

Pt was seen in our medical practice for complaint of swelling, bruising, and "lots of small bumps" status post injection of a non-fda approved dermal filler three days prior.The pt was accompanied by her friend, an aesthetician, who performed the injection using the "hyaluron pen" device at an injection training sponsored by (b)(6).The aesthetician reports using a dermal filler product from (b)(6), gana r&d, reportedly obtained online.Injection materials were reportedly obtained from (b)(6) by the training facilitator.The pt reports when she addressed her concern of abnormal swelling and bumps with the trainer, she was told to "go to a dr to get it dissolved." assessment revealed swelling, bruising, and small lesions without drainage to the upper and lower lips.No permanent damage or disability noted at this time.Pt will f/u with the provider in one week.The pt and the aesthetician reported that the injection "training" courses with the non-fda approved materials are being offered in the (b)(6) areas.The training website provided by the aesthetician, (b)(6), reports courses are being offered throughout (b)(6)."cn".Fda safety report id# (b)(4).

• Brand Name: HYALURON PEN
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 9632444
• MDR Text Key: 176669035
• Report Number: MW5092530
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR