BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

    MDR report key: 10565917 · Received September 22, 2020

    Report

    Report Number
    2214133-2020-00035
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    April 28, 2018
    Report Date
    August 28, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    3574661329499
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661329499 LTCMA11827EUA LTCMA11827EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB). UDI: (B)(4). UPC = (01)3574661329499, EXP DATE = (17)200531, LOT NUMBER = (10)1707KS06. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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 JUNE 19, 2017. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION OF AN INVESTIGATION TO DETERMINE IF THE DEVICE IS ASSOCIATED WITH THIS EVENT. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R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# 83291). 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 WAS RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE WHO REPORTED USING NTG VISIBLY CLEAR LIGHT THERAPY MASK DAILY FOR 2 MONTHS (FROM (B)(6) 2018 TO (B)(6) 2018) FOR ACNE. AFTER APPROXIMATELY 1 MONTH OF PRODUCT USE ((B)(6) 2018), SHE EXPERIENCED ¿HEADACHES/ VERY BAD MIGRAINES¿. SHE VISITED THE DOCTOR AND WAS TREATED WITH UNSPECIFIED PAINKILLERS OF UNSPECIFIED DOSAGES AND ONGOING REVIEW. THERE IS NO INFORMATION ON CONCOMITANT DISEASES, CONCOMITANT MEDICATIONS BEING TAKEN OR MEDICAL HISTORY. THERE ARE NO DETAILS ON CONSULTATIONS, ANY EXAMINATIONS CONDUCTED/ THE RESULTS OF WHICH OR THE DIAGNOSIS. THE CONSUMER MENTIONED THAT UPON DISCONTINUATION OF PRODUCT USE, THERE WAS RESOLUTION OF THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030191 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OTC OLP JOHNSON & JOHNSON CONSUMER INC 3574661329499 1707KS06 3574661329499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention