BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT

    MDR report key: 8270858 · Received January 23, 2019

    Report

    Report Number
    2214133-2019-00061
    Event Type
    Injury
    Date Received
    January 23, 2019
    Report Date
    December 29, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K160691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, SEX, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE SPOT TREATMENT USA (B)(4). LOT # IS NOT AVAILABLE. (B)(4), EXPIRATION DATE= NI, LOT NUMBER = 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. 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 INCIDENT AFTER USING THE NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. CONSUMER HAS BEEN USING THE DEVICE FOR TWO DAYS FOR HIS/HER PIGMENT; HOWEVER, THE CONSUMER ALLEGED IT HAS ONLY MADE IT WORSE. CONSUMER STATES THAT HIS/HER SKIN IS EVEN MORE DRY AND RED AND BURNS. THE CONSUMER ALSO STATES THAT HE/SHE HAS BEEN HAVING SEVERE HEADACHES. CONSUMER'S DERMATOLOGIST HAS BEEN GIVING THE CONSUMER MULTIPLE PRESCRIPTIONS AND THE SYMPTOMS HAVE NOT RESOLVED. CONSUMER STATES THAT HIS/HER FACE IS GETTING WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63103 NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC 70501101315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention