BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTG LIGHT THERAPY ACNE SPOT TREATMENT

    MDR report key: 9150357 · Received October 3, 2019

    Report

    Report Number
    2214133-2019-00116
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Report Date
    September 5, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    70501101315
    PMA / PMN Number
    K160691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315 7050110131USA 7050110131USA. LOT # IS NOT AVAILABLE. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 FEMALE CONSUMER REPORTED AN EVENT WITH NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. THE CONSUMER ALLEGED THAT THE PRODUCT STARTED TO GET HOT, SMOKE AND THE BATTERY STARTED TO LEAK. CONSUMER STATED THAT SHE SPRAYED THE PRODUCT WITH A MINI FIRE EXTINGUISHER AS A PRECAUTION. THE CONSUMER USED THE PRODUCT FOR TWO DAYS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944554 NTG LIGHT THERAPY ACNE SPOT TREATMENT OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC 70501101315 70501101315

    Patients

    Seq Age Sex Outcome Treatment
    1