BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTG LIGHT THERAPY ACNE MASK

    MDR report key: 12085668 · Received June 29, 2021

    Report

    Report Number
    2214133-2021-00021
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    February 1, 2018
    Report Date
    June 4, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC.
    Product Code
    OLP
    UDI-DI
    3574661330617
    PMA / PMN Number
    K123999
    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. PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661330617 LTCMA11836EUA). 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). UDI: (B)(4), UPC = 3574661330617, LOT # 0067KS06, EXP. DATE - NOV-30-2019. 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). 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 JANUARY 6, 2017. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. ALTHOUGH THE CONSUMER CONSULTED AN OPHTHALMOLOGIST, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE NATURE OF THE EYE CONDITION AND WHETHER IT IS POTENTIALLY CAUSALLY RELATED TO PRODUCT USE AS THERE IS NO INFORMATION ON AGE OF THE CONSUMER, MEDICAL HISTORY, CONCOMITANT MEDICATIONS, PROGRESSION OF THE CONDITION, RESULTS OF MEDICAL CONSULTATIONS OR DIAGNOSTICS DONE, FINAL DIAGNOSIS AND THE REASON FOR THE USE OF THE GLASSES. THERE IS INSUFFICIENT INFORMATION TO CONCLUDE WHETHER A PERMANENT INJURY OR IMPAIRMENT OCCURRED AS THERE NO DETAILS FOR FURTHER ASSESSMENT AND THE REASON FOR THE USE OF GLASSES WAS NOT SPECIFIED. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R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). THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2021-00021. THIS MEDWATCH IS FOR HUSBAND'S COMPLAINT. 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

    HUSBAND'S COMPLAINT - A CONSUMER REPORTED FOR HERSELF AND FOR HER HUSBAND OF UNSPECIFIED AGE WHO USED NTG LIGHT THERAPY ACNE MASK USA IN (B)(6) 2017 FOR ACNE ONCE DAILY AND ON (B)(6) 2018, HE STARTED EXPERIENCING UNSPECIFIED EYE PROBLEMS (DESCRIBED AS DIMINISHED VISION) WHICH PROMPTED CONSULT WITH AN OPHTHALMOLOGIST AT AN UNSPECIFIED TIME AND USE OF UNSPECIFIED GLASSES FOR AN UNSPECIFIED INDICATION. NO INFORMATION ON ANY TEST CONDUCTED, RESULTS, DIAGNOSIS, RELEVANT MEDICAL HISTORY, AND CONCOMITANT MEDICATIONS HAS BEEN PROVIDED. THE CONSUMER DISCONTINUED USE OF THE PRODUCT AT AN UNSPECIFIED TIME AND AT THE TIME OF REPORTING THE SYMPTOMS WERE STILL PRESENT. THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. THIS MEDWATCH IS FOR HUSBAND'S COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981801 NTG LIGHT THERAPY ACNE MASK OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC. 3574661330617 0067KS06 3574661330617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other