BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA® LIGHT THERAPY ACNE MASK

    MDR report key: 8640322 · Received May 24, 2019

    Report

    Report Number
    2214133-2019-00076
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    April 30, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ETHNICITY: PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. BRAND NAME: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA). COMMON DEVICE NAME, PROCODE, MFR, LOT #, EXPIRATION DATE, PART #: THIS REPORT IS FOR (NTG LIGHT THERAPY ACNE MASK CAN 62600965035). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 70501101247). LOT# AND EXPIRATION DATE IS UNKNOWN. (B)(4). DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER AND A PRODUCT LOT NUMBER WAS NOT REPORTED. (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 FEMALE CONSUMER REPORTED FOLLOWING THE USE OF THE NEUTROGENA LIGHT THERAPY ACNE MASK SHE EXPERIENCED AN ACNE BREAKOUT. THE CONSUMER CONTINUED TO USE THE PRODUCT FOR TWO ADDITIONAL SESSIONS AND NOTED THAT SHE EXPERIENCED CYSTIC PIMPLES WITH WHITE PUS AND REDNESS. THE CONSUMER NOTED THEY USED 3-4 SESSIONS IN TOTAL AND EXPERIENCED THE REACTION AFTER THE FIRST USE. THE CONSUMER STOPPED USING THE PRODUCT AND PURCHASED TREATMENT FROM THE PHARMACY (OVER THE COUNTER MEDICATION AND CREAMS). THE CONSUMER ALSO NOTED SHE HAD SCARS AND WAS EXPERIENCING SEVERE ACNE THAT REQUIRED CONSULTATION WITH A DERMATOLOGIST. TREATMENT BY THE DERMATOLOGIST WILL INCLUDE MICRO-NEEDLING SESSIONS AND ACCUTANE (PRESCRIPTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434885 NEUTROGENA® LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC 062600965035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention