MAUDE Adverse Event Report: TRISTAR ONE TRISTAR ONE- PHOTONS SYSTEM; POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING AFFECT FOR ADJ

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Rash (2033)

Event Date 07/24/2019

Event Type  Injury  

Event Description

After using an led light therapy device purchased on (b)(6), i have developed a severe rash requiring cortisone treatment.It has also triggered my asthma which has also required treatment with a steroid.Did the problem stop after the person reduced the dose or stopped taking or using the product? no.Date the person first started taking or using the product: (b)(6) 2019.Date the person stopped taking or using the product: (b)(6) 2019.Why was the person using the product? treating sun damage on arms.

• Brand Name: TRISTAR ONE- PHOTONS SYSTEM
• Type of Device: POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING AFFECT FOR ADJ
• Manufacturer (Section D): TRISTAR ONE
• MDR Report Key: 8857086
• MDR Text Key: 153428152
• Report Number: MW5088700
• Device Sequence Number: 1
• Product Code: NHN
• Combination Product (y/n): N
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 72