BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTG LIGHT THERAPY ACNE MASK USA

    MDR report key: 8743777 · Received June 28, 2019

    Report

    Report Number
    2214133-2019-00085
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    July 9, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DATA: COUNTY UPDATED TO AUSTRALIA UPON RECEIVING ADDITIONAL INFORMATION FROM CONSUMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR NTG LIGHT THERAPY ACNE MASK USA 70501101247 (B)(4). LOT NUMBER IS NOT AVAILABLE. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE COMPLETED WITH A LOT NUMBER. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2019-00084 (DAUGHTER). THE MOTHER AND THE DAUGHTER ARE INDIVIDUALLY REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A MOTHER ALLEGED VIA SOCIAL MEDIA AN EVENT WITH THE NTG LIGHT THERAPY ACNE MASK FOR BOTH HER AND HER DAUGHTER. THE CONSUMER STATED THAT BOTH DEVELOPED CYSTS ON THEIR NOSES. THE CONSUMER STATED THAT NEITHER OF THEM EVER HAD CYSTS BEFORE THIS INCIDENT. AS PER THE MOTHER, THE DAUGHTER¿S CYST IS BLACK, AND THE MOTHER HAS TWO SMALLER CYSTS (NOT BLACK). THE CONSUMERS SOUGHT MEDICAL ATTENTION FROM A HEALTH CARE PROFESSIONAL (HCP). THE CONSUMER STATED THAT THE HCP SAID A PLASTIC SURGEON WOULD BE NEEDED TO REMOVE THE CYSTS. THIS IS ALL THE KNOWN INFORMATION AVAILABLE AT THIS TIME. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2019-00084 (DAUGHTER). THE MOTHER AND THE DAUGHTER ARE INDIVIDUALLY REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539697 NTG LIGHT THERAPY ACNE MASK USA ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention