BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYLIGHT

    MDR report key: 10985135 · Received December 10, 2020

    Report

    Report Number
    3017060146-2020-00001
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    July 25, 2020
    Report Date
    November 16, 2020
    Manufacturer
    RAJA TRADING COMPANY, INC.
    Product Code
    GEX
    PMA / PMN Number
    K200104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 12, 2020, MANUFACTURER WAS MADE AWARE OF A POTENTIAL INJURY (THE SEVERITY OF WHICH IS UNCLEAR) DESCRIBED IN A VOLUNTARY MDR FILED BY A CONSUMER (REPORT NUMBER MW5097129). HOWEVER, THE MANUFACTURER IS NOT ABLE TO CONDUCT AN INVESTIGATION SINCE NO COMPLAINT WAS FILED DIRECTLY WITH THE MANUFACTURER AND THE MANUFACTURER HAS NO INFORMATION ON WHO THE CONSUMER IS, WHERE THE INCIDENT OCCURRED AND WHETHER OR NOT THE INJURY RISES TO THE LEVEL OF A SEVERE ONE THAT IS REQUIRED TO BE REPORTED. IN ADDITION, THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE INCIDENT CAN NOT BE INVESTIGATED. FINALLY, MANUFACTURER HAS NOT RECEIVED ANY OTHER COMPLAINTS REGARDING THE DEVICE. ACCORDINGLY, MANUFACTURER HAS CLOSED ITS FILE REGARDING THE INCIDENT. NOTE: THE MANUFACTURER'S SUBMISSION WAS LATE DUE TO THE ESG ENROLLMENT PROCESS.

    Description of Event or Problem · 1

    ACCORDING TO A VOLUNTARY MDR (MW5097129) FILED WITH THE FDA BY A CONSUMER, THE CONSUMER VISITED AN UNIDENTIFIED MEDICAL SPA TO RECEIVE A FACIAL SERVICE. THE AESTHETICIAN USED A DEVICE, EITHER THE IONIXLIGHT OR OXYLIGHT, THAT, ACCORDING TO THE CONSUMER CAUSED: (1) SEVERE "HEATING" TO THE CONSUMER'S SKIN; (2) EXTREME SENSITIVITY TO THE CONSUMER'S ENTIRE FACE; (3) TWITCHING NEAR THE CONSUMER'S EYES; AND (4) BLURRED VISION FOR AN UNSPECIFIC NUMBER OF DAYS FOLLOWING THE FACIAL. THE CONSUMER INDICATED THAT THE LED AND MICROCURRENT WERE TOO STRONG, CAUSING MUSCLE TWITCHING AND HIS/HER EYE AREA TO BE OVERLY SENSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448100 OXYLIGHT OXYLIGHT GEX RAJA TRADING COMPANY, INC. NOT APPLICABLE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other