BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT

    MDR report key: 8433696 · Received March 19, 2019

    Report

    Report Number
    2214133-2019-00065
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Report Date
    February 23, 2019
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K160691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315. LOT # IS NOT AVAILABLE. UDI # (B)(4), UPC: (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. 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 NTG LIGHT THERAPY ACNE SPOT TREATMENT USA. THE CONSUMER WAS USING THE NTG LIGHT THERAPY ACNE SPOT TREATMENT FOR A SMALL PIMPLE ON HER FACE. THE CONSUMER HAS ALLEGED THAT THE NTG LIGHT THERAPY ACNE SPOT TREATMENT STARTED TO SMELL AND SPARK. CONSUMER ALLEGED BURN TO FACE AND MIDDLE FINGER ON HER RIGHT HAND. CONSUMER STATED THAT HER FACE AND FINGER BLISTERED AND A WEEK AFTER THE EVENT SHE STILL HAD MARKS ON BOTH HER FACE AND FINGER. CONSUMER RECEIVED MEDICAL ATTENTION WHILE AT HER PLACE OF EMPLOYMENT, AN EMERGENCY ROOM (ER). CONSUMER WAS TOLD TO KEEP APPLYING AN UNKNOWN ANTIBIOTIC CREAM TO PREVENT INFECTION AND THAT IT WILL TAKE TIME TO HEAL THE BURN AND BROKEN SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226290 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