BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTG LIGHT THERAPY ACNE MASK

    MDR report key: 9404988 · Received December 3, 2019

    Report

    Report Number
    2214133-2019-00134
    Event Type
    Injury
    Date Received
    December 3, 2019
    Report Date
    November 7, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    70501101247
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, SEX, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB. LOT # IS NOT AVAILABLE. UDI # (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. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. (B)(4). 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 CONSUMER REPORTED AN EVENT WITH NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER USED THE LIGHT THERAPY MASK TO TREAT ACNE FOR AN UNKNOWN FREQUENCY AND DURATION AND REPORTED NOTICING THAT HIS/HER EYES WERE ¿EASILY IRRITATED¿. THE CONSUMER STOPPED USING THE PRODUCT, DUE TO THE IRRITATION AND THAT HIS/HER ACNE CLEARED. THE CONSUMER STARTED USING THE PRODUCT AGAIN AND NOTICED THAT THE EYES BECAME IRRITATED. THE CONSUMER MENTIONED HAVING ¿SENSITIVE¿ SKIN BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE CONSUMER VISITED PHYSICIANS WHO SUPPOSEDLY SAW ¿IRRITATION¿ AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR AN UNSPECIFIED INDICATION. THERE IS NO INFORMATION ON ANY DIAGNOSTICS DONE, THE DIAGNOSIS, TREATMENT AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199068 NTG LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC 70501101247 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention