BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASLIM RED LIGHT THERAPY

    MDR report key: 16573839 · Received March 17, 2023

    Report

    Report Number
    MW5115842
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    January 24, 2023
    Manufacturer
    WARD PHOTONICS LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON MY 3RD VISIT FOR ULTRASLIM RED LIGHT THERAPY 2 BLISTERS OCCURRED ON MY LEFT BREAST MEDIAL. THE TREATMENT WAS FOR MY NECK BUT THE LIGHT WAS SO POSITIONED THAT IT COVERED OVER MY LEFT BREAST WHICH. I WAS WEARING A TWO LAYER CAMISOLE AND NO ADDITIONAL COVERING WAS USED. I TOLD THE OWNER ABOUT THE BLISTERS WHEN SHE RETURNED FROM BEING OUT OF TOWN. THE NEXT TREATMENTS WERE DONE USING A MAT THAT COVERED THAT AREA. WHO KNEW THIS WOULD BECOME COMPLICATED. I DIDN'T HEAL WELL AS I'VE HAD MANY RECONSTRUCTIVE SURGERIES ON MY CHEST AS I AM A BREAST CANCER SURVIVOR. I HAVE SEEN MANY DOCTORS AND I WAS TOLD IT WOULD PROBABLY HAVE TO HAVE A REVISION SURGERY ON THAT BREAST. THE OWNER (MELISSA) WAS REALLY SORRY ABOUT IT AND WANTED TO TALK TO MR WARD THE DEVELOPER OF THE RED LIGHT THERAPY. I JUST THOUGHT THE FDA SHOULD KNOW ABOUT THIS HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937888 ULTRASLIM RED LIGHT THERAPY POWERED LASER SURGICAL INSTRUMENT GEX WARD PHOTONICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R