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U.S. Department of Health and Human Services

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

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BLUE LIGHT TREATMENT POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT Back to Search Results
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.
 
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Brand NameBLUE LIGHT TREATMENT
Type of DevicePOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT
MDR Report Key10224279
MDR Text Key197598445
Report NumberMW5095348
Device Sequence Number1
Product Code ONF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 07/01/2020 Patient Sequence Number: 1
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