BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED LIGHT LASER TREATMENT

    MDR report key: 11664109 · Received April 13, 2021

    Report

    Report Number
    MW5100775
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 13, 2021
    Manufacturer
    UNK
    Product Code
    NHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT AN ADVERSE REACTION TO RED LIGHT LASER TREATMENT SHE RECEIVED FOR NEUROPATHY PAIN IN MID JANUARY. PATIENT STATED THAT SHE SAW IT ADVERTISED IN THE NEWSPAPER AND DECIDED TO TRY IT. PATIENT STATED WHEN SHE WENT, A RED-LIGHT LASER WAS WRAPPED AROUND THE MIDDLE OF HER BODY AND SHE WOULD SIT THERE FOR ABOUT 20-30 MINUTES, SHE DID THIS A COUPLE TIMES A WEEK. PATIENT STATED AFTER HER SECOND WEEK OF TREATMENT SHE STARTED EXPERIENCING NECK PAIN ON THE SIDE OF HER NECK. PATIENT SAID WHEN SHE WENT BACK FOR THE NEXT TREATMENT A SMALL LASER LIGHT THAT PRODUCED A SMALL AMOUNT OF HEAT WAS USED. PATIENT STATED AFTER THAT SECOND LASER TREATMENT SHE FELT LIKE SHE WAS GOING TO PASS OUT. PATIENT SAID WHEN SHE GOT HOME, SHE ATE A SNACK AND LAID DOWN FOR A COUPLE HOURS. PATIENT SAID AT HER NEXT TREATMENT APPOINTMENT SHE TOLD THE PROVIDING DOCTOR ABOUT HER EXPERIENCE AND SHE DID NOT GET ANY LASER TREATMENT THAT DAY. PATIENT STATED SHE DECIDED TO STOP GOING TO THE TREATMENT CENTER. PATIENT SAYS SHE STILL HAS DIZZINESS IN HER HEAD, SHE FELT EXTREMELY TIRED FOR WEEKS FOLLOWING THE LASER TREATMENT, AND JUST DIDN'T FEEL LIKE HERSELF. PATIENT STATED SHE HAD INCREASED BLOOD PRESSURE AND JUST FELT LIKE SHE NEEDED TO SLEEP A LOT. PATIENT STATED IT TOOK A FEW WEEKS TO FEEL BACK TO HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555726 RED LIGHT LASER TREATMENT POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJ NHN UNK
    555727 SMALL LASER LIGHT POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJ NHN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other