MAUDE Adverse Event Report: BLUE LIGHT TREATMENT; POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Pain (1994); Vomiting (2144); Burning Sensation (2146)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Patient called to report an adverse event he experienced while receiving blue light therapy at his dermatologist.Patient stated that the therapy was supposed to last 16 minutes, but he barely lasted six minutes due to an intense burning sensation that felt sizzling hot.The patient stated that the following day, he experienced severe headaches and spent the entire night vomiting.Patient said he couldn't sleep due to the pain and vomiting and is still having headaches today.

• Brand Name: BLUE LIGHT TREATMENT
• Type of Device: POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT
• MDR Report Key: 10224279
• MDR Text Key: 197598445
• Report Number: MW5095348
• Device Sequence Number: 1
• Product Code: ONF
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR