BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT

    MDR report key: 8238764 · Received January 11, 2019

    Report

    Report Number
    2214133-2019-00059
    Event Type
    Injury
    Date Received
    January 11, 2019
    Report Date
    December 13, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K160691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, SEX, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315). THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT AP 6907376834465, 26202392APA, 26202392APA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315). (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315). DEVICE EVALUATION/INVESTIGATION 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

    IT WAS REPORTED THAT THE CONSUMER EXPERIENCED AN ALLERGY AFTER USING THE NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. THE CONSUMER SOUGHT MEDICAL ATTENTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED OR RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33891 NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC 6907376834465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention