BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU

    MDR report key: 7659146 · Received July 3, 2018

    Report

    Report Number
    2214133-2018-00025
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 3, 2018
    Report Date
    July 12, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK (B)(4)). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK KIT USA (B)(4)). (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: EBASTEL, CONSUMER STILL ON DRUG. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK KIT USA (B)(4)). 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. 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 MOTHER OF A (B)(6) DAUGHTER REPORTED THAT HER DAUGHTER HAS USED THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK FOR 10 MINUTES DAILY AND ON THE 4TH DAY, (B)(4) 2018, THE CONSUMER NOTICED AS IF HER FACE WAS BURNED. THE CONSUMER VISITED THE HOSPITAL EMERGENCY ROOM BECAUSE SHE SAW THE BURNS ON THE CHEEKBONES, NOSE, CHIN AND FOREHEAD. THE DOCTOR RECOMMENDED THE PATIENT TO USE A MOISTURIZER (AVENE CREME) AND MAXIMUM SUN PROTECTION TO AVOID POSSIBLE SPOTS AFTER THE DESQUAMATION. IT WAS REPORTED THAT CONSUMER¿S FACE SKIN IS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503266 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC AN3LTCMA91806 3417KS06

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention EBASTEL| EBASTEL