BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA® LIGHT THERAPY ACNE MASK

    MDR report key: 7018563 · Received November 10, 2017

    Report

    Report Number
    2214133-2017-00008
    Event Type
    Injury
    Date Received
    November 10, 2017
    Report Date
    October 13, 2017
    Manufacturer
    KINSENG PLASTICS CO. LTD.
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. EXACT DATE OF THE EVENT IS UNKNOWN. CONSUMER REPORTED THE EVENT OCCURRED SEVERAL WEEKS PRIOR TO THE J AND J AWARENESS DATE. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON AN UNSPECIFIED DATE, IN 2017, FEW WEEKS PRIOR TO REPORTING, THE CONSUMER STARTED USING NEUTROGENA LIGHT THERAPY ACNE MASK. AFTER USING IT FOR ABOUT 10 SECONDS HER EYES STARTED BURNING AND HURTING. SHE TRIED IT FOR ANOTHER SHORT WHILE (LESS THAN A MINUTE) WITH A THICK SOCK COVERING EYES BUT IT WAS STILL PAINFUL. AFTERWARDS HER VISION WAS BLURRY, EYES WERE PAINFUL AND EYELIDS WERE HOT AND PUFFY. ON AN UNSPECIFIED DATE, IN 2017, SHE VISITED ER (EMERGENCY ROOM) WHERE SHE WAS DIAGNOSED WITH OPTIC NEURITIS. SHE WAS PRESCRIBED UNSPECIFIED OINTMENT TO PUT IN EYES. WHILE REPORTING THE CONSUMER MENTIONED THAT HER VISION MOSTLY RETURNED TO NORMAL ALTHOUGH THERE STILL WAS SOME EXCESSIVE LIGHT SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797774 NEUTROGENA® LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OLP KINSENG PLASTICS CO. LTD. 070501101247 2426KS06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention