BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU

    MDR report key: 7541221 · Received May 24, 2018

    Report

    Report Number
    2214133-2018-00007
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    September 30, 2017
    Report Date
    April 30, 2018
    Manufacturer
    KINSENG PLASTICS CO. LTD.
    Product Code
    OLP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT AND ETHNICITY 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 MASK USA). (B)(4). LOT # WAS NOT PROVIDED. 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 MASK USA). (B)(4). 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

    A CONSUMER CALLED ABOUT THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK SHE WAS USING FOR ACNE TREATMENT. THE CONSUMER STARTED USING THE DEVICE ON (B)(6) 2017 FOR DAILY TREATMENT. SINCE (B)(6) 2017 SHE IS ALLEGING THAT HER EYES HAVE BEEN DRY AND THAT SHE IS SENSITIVE TO THE SUNLIGHT. CONSUMER WAS SEEN BY A HEALTH CARE PROFESSIONAL WHO PRESCRIBED CORTISONE FOR TREATMENT. CONSUMER HAS ALSO BEEN USING A TEAR SUBSTITUTE FOR 2-3 MONTHS. CONSUMER IS ALLEGING DAMAGE TO THE CORNEAS AND SYMPTOMS ASSOCIATED WITH THE DISEASE SICCA (DRY EYES). SYMPTOMS HAVE NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385035 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU ACNE LIGHT THERAPY SYSTEM OLP KINSENG PLASTICS CO. LTD. AN3LTCMA11836

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention AMLODIPIN| OMEGA 3| VOLTAREN