MAUDE Adverse Event Report: JET PRO PLASMA; MASSAGER, THERAPEUTIC, ELECTRIC

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The outlet didn't charge the device.After an hour, and changing the outlet (plug) the device did not work.The distributor and trainer for jet pro (cold) plasma (profosma) claims that the device is fda regulated.I purchased a used device from another beauty professional and found the device to not work consistently and thankfully i sold it on the private market.Distributor will not sell replacement tips to owners that have bought the device second hand.The device then becomes useless.The price for the device is (b)(6).The device is made in china and the us "exclusive" distributor ((b)(6)) states that the product is us fda regulated.I believe this to be untrue and fabricated information that (b)(6) has been advertising on social media.There is price fixing and business monopolization evident with her business.The device is dangerous.There have been many device owners returning their devices for faulty issues.I couldn't because mine was second hand.I had an engineer fix mine.Thankfully.Many people are afraid to report this for fear of retribution by (b)(6) and her partner (b)(6) as seen and noted in jet plasma pen facebook group.The device or charging port doesn't have any compliance or noted ul(underwriters laboratories), iso(international organization for standardization) or ce(conformite europeenne) requirements.The outlet didn't charge the device.The distributor and trainer for jet pro plasma (profosma) states that the device is fda regulated, i purchased a used device and found it to not work consistently and sold it on the private market.The device is made in china and yet the us distributor ((b)(6)) states that the product is us fda regulated.Please investigate, thank you.Refer to add'l documents in i2k.

• Brand Name: JET PRO PLASMA
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• MDR Report Key: 18300959
• MDR Text Key: 330255860
• Report Number: MW5149046
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White