BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA® LIGHT THERAPY ACNE MASK

    MDR report key: 8700855 · Received June 14, 2019

    Report

    Report Number
    2214133-2019-00083
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    March 11, 2018
    Report Date
    June 17, 2019
    Manufacturer
    JOHNSON AND JOHNSON CONSUMER INC.
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H4, H6: 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. THIS PRODUCT WAS MANUFACTURED ON OCTOBER 27, 2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE, ETHNICITY: DATE OF BIRTH AND ETHNICITY/RACE WERE NOT PROVIDED FOR REPORTING. UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION, DEVICE EVALUATED BY MFR: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. AT THIS TIME, WITH THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. THE CONSUMER WAS DIAGNOSED WITH IDIOPATHIC CRANIAL HYPERTENSION WHICH CLINICAL MANIFESTATIONS CORRELATING WITH HEADACHE, VISION LOSS AND PAPILLEDEMA FOUND IN THE EYE EXAMINATION. RETINAL EVALUATION WAS UNREMARKABLE. THERE IS NO EVIDENCE OF A POTENTIAL CAUSAL ASSOCIATION BETWEEN LIGHT THERAPY MASK AS A TRIGGER OR CAUSE OF THIS CONDITION. 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 (B)(6) FEMALE CONSUMER & HER ATTORNEY REPORTED AN EVENT WITH NTG LIGHT THERAPY ACNE MASK. THE CONSUMER STATES THAT SHE WAS USING THE PRODUCT FROM (B)(6) 2018, FOR A TEN-MINUTE SESSION, ONCE DAILY, FOR ACNE TREATMENT. AFTER USE THE CONSUMER ALLEGES THAT SHE SAW BLACK BLOTCHES FOR 1-2 HOURS. ON (B)(6) 2018, THE CONSUMER SOUGHT MEDICAL ATTENTION FOR AN EXAMINATION COMPLAINING OF DECREASED VISION. SHE WAS FOUND TO HAVE HYPEROPIA IN BOTH EYES AND ABNORMAL OPTIC NERVE HEADS IN BOTH EYES. ON (B)(6) 2018 A SERIES OF TESTS WERE PERFORMED, AND THE CONSUMER WAS DIAGNOSED WITH BILATERAL MACULAR DRUSEN AND IDIOPATHIC INTRACRANIAL HYPERTENSION. HER RETINAL EVALUATION WAS NORMAL. THE CONSUMER HAS COMPLAINTS OF HEADACHES ONCE A WEEK THAT ARE TRIGGERED BY BRIGHT LIGHT. THE SYMPTOMS HAVE NOT RESOLVED, AND THE CONSUMER¿S HEALTH CARE PROFESSIONAL REQUESTED THAT SHE RETURN TO THE FACILITY IF HER EYES BECOME WORSE AND IF THE OPTIC DISCS ARE STILL SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493390 NEUTROGENA® LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OLP JOHNSON AND JOHNSON CONSUMER INC. 70501101247 3007KS05

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention