BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

    MDR report key: 10163533 · Received June 17, 2020

    Report

    Report Number
    2214133-2020-00015
    Event Type
    Injury
    Date Received
    June 17, 2020
    Report Date
    June 1, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    OLP
    UDI-DI
    70501101247
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A5: PATIENT RACE WAS NOT PROVIDED FOR REPORTING. UDI: (B)(4). UPC = (01)70501101247 EXP DATE = (17)200930 LOT NUMBER = (10)3047KS05. 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 AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON OCTOBER 31, 2017. (B)(4). THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R RES# (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

    THIS CASE FROM A GRANDPARENT WHO REPORTED THAT HER TEENAGE GRANDSON USED THE NTG LIGHT THERAPY ACNE MASK TO TREAT HIS ACNE ONCE A WEEK FOR 10 MINUTES (BETWEEN (B)(6) AND (B)(6) 2019) AND EXPERIENCED MIGRAINES AT AN UNSPECIFIED TIME WITHIN 6 TO 8 HOURS OF USING THE PRODUCT. THE CONSUMER CONSULTED WITH A HEALTH CARE PROFESSIONAL WHO RECOMMENDED TREATMENT WITH UNSPECIFIED DOSES OF PROPRANOLOL. THERE WERE NO DIAGNOSTICS/ LABORATORY WORKUPS DONE. THE GRANDMOTHER MENTIONED THAT THE SYMPTOMS IMPROVED WHEN THE CONSUMER DISCONTINUED USING THE PRODUCT AT AN UNSPECIFIED TIME AND AS OF (B)(6) 2019, THE CONSUMER WAS NO LONGER EXPERIENCING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628982 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OTC OLP JOHNSON & JOHNSON CONSUMER INC. 70501101247 3047KS05 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention