BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTG LIGHT THERAPY ACNE MASK USA

    MDR report key: 9365252 · Received November 22, 2019

    Report

    Report Number
    2214133-2019-00131
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    October 28, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247, 7050110124USB. LOT # IS NOT AVAILABLE. UDI # (B)(4); LOT NUMBER = NI; EXP DATE: NI. 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 THE NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER REPORTED THAT WHEN SHE TRIED TO OPEN IT, THE LIGHTS FLASHED FOR JUST A MINUTE AND IT STARTED TO SMOKE A LITTLE BIT. THERE WAS NO ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157729 NTG LIGHT THERAPY ACNE MASK USA ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1