BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT

    MDR report key: 10636968 · Received October 6, 2020

    Report

    Report Number
    2214133-2020-00037
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    3574661383606
    PMA / PMN Number
    K160691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT AP 3574661383606 26202035APA). 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 7050110131USA). UPC = (01)3574661383606, EXP DATE = (17)220228, LOT NUMBER = (10) 0689KS04, UDI: (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT AP 3574661383606 26202035APA). 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 7050110131USA). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON MARCH 9, 2019. (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 AN ADVERSE EVENT FOR NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT AP. CONSUMER REPORTED THAT SHE USED THE DEVICE ON ONE SIDE OF HER FACE IN THE MORNING AND IN THE EVENING BEFORE BED. WHEN THE CONSUMER WOKE UP THE NEXT MORNING SHE ALLEGED THAT SHE HAD THE WORST SCARRING WHERE SHE APPLIED THE DEVICE. SHE ALLEGED THAT IT HAD BURNED HER SKIN. CONSUMER SOUGHT MEDICAL ATTENTION AND RECEIVED MEDICAL INTERVENTION. THE HEALTH CARE PROFESSIONAL PRESCRIBED MOMETASONE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098646 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT OTC POWERED LIGHT BASED LASER OLP JOHNSON & JOHNSON CONSUMER INC 3574661383606 0689KS04 3574661383606

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention