BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTG LIGHT THERAPY ACNE MASK

    MDR report key: 11608253 · Received April 2, 2021

    Report

    Report Number
    2214133-2021-00014
    Event Type
    Injury
    Date Received
    April 2, 2021
    Report Date
    April 21, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    70501101247
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. UPDATED SECTIONS: D9 - FIELD SAMPLE WAS RETURNED AT JOHNSON & JOHNSON ON APRIL 21, 2021. H3: A FIELD SAMPLE WAS RECEIVED FOR ONE PREVIOUSLY OPENED NTG LIGHT THERAPY ACNE MASK USA (B)(4) LOT 3506KS04 EXPIRATION DATE 2018-12-14. FIELD SAMPLE WAS EVALUATED AGAINST SHELF-LIFE SPECIFICATIONS FROM MANUFACTURING SITE. THE RED AND BLUE LIGHTS OF THE MASK TURNED ON, AND THE RED AND BLUE LIGHTS TURNED OFF AFTER RUNNING FOR 10 MINUTES AND 5 SECONDS, AND FUNCTION AS NORMAL. THE MASK TEST RESULT MEET SPECIFICATIONS, NO ABNORMALITY OCCURRED BASED ON MANUFACTURING SITE EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. UDI #: (B)(4). UPC #: 70501101247 EXP DATE: 14-DEC-2018. LOT #: 3506KS04. 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 DEC 15, 2016. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. WHILE THE EXPOSURE TO BRIGHT LIGHTS MAY HAVE POSSIBLY TRIGGERED THE MIGRAINE AT THE TIME THAT THE CONSUMER WAS USING THE PRODUCT (APPROXIMATELY 3 YEARS AGO), THE LIMITED INFORMATION AND MULTIPLE TRIGGERS OF MIGRAINES PRECLUDES A MORE MEANINGFUL ASSESSMENT. IN ADDITION, FURTHER ANALYSIS OF THIS CASE IS CONFOUNDED BY THE PRE-EXISTING HISTORY OF LIGHT SENSITIVITY WHICH MAY PROVIDE AN ALTERNATE EXPLANATION. BASED ON THE LIMITED INFORMATION AVAILABLE, THE CONDITION NECESSITATED A CONSULTATION WITH AN HCP AND THE CONSUMER UNDERWENT A CT SCAN AND WAS GIVEN UNSPECIFIED MIGRAINE MEDICATIONS. HOWEVER, THERE ARE NO DETAILS ON THE MEDICAL HISTORY, ANY CONCOMITANT MEDICATIONS BEING USED, ACCOMPANYING SIGNS AND SYMPTOMS, RESULTS OF THE CT SCAN AND THE SPECIFIC MEDICATIONS USED. OF NOTE, THERE IS NO INFORMATION TO SUGGEST THAT CURRENT SYMPTOMS OF MIGRAINE THAT THE CONSUMER IS EXPERIENCING IS RELATED TO PRODUCT USE. 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 (B)(6)-YEAR OLD FEMALE, WITH HISTORY OF LIGHT SENSITIVITY WHO USED THE NTG LIGHT THERAPY MASK FOR AN UNSPECIFIED DATE (FROM 2016 TO 2017) TO TREAT HER ACNE ONCE A DAY FOR AN UNSPECIFIED DURATION AND EXPERIENCED MIGRAINES EVERY TIME SHE WAS EXPOSED TO LIGHT (OF UNSPECIFIED SOURCE) WHICH STARTED ABOUT 3 YEARS AGO. ACCORDING TO THE CONSUMER, SHE CONSULTED AN HEALTH CARE PROFESSIONAL AT AN UNSPECIFIED DATE, AND SHE UNDERWENT A CT SCAN AND SHE WAS GIVEN UNSPECIFIED MIGRAINE MEDICATIONS. THERE IS NO INFORMATION ON THE RESULTS OF THE CT SCAN. APART FROM THE LIGHT SENSITIVITY MENTIONED ABOVE, THERE ARE NO OTHER REPORTED MEDICAL CONDITIONS OR RELEVANT HISTORY. FURTHERMORE, THERE ARE NO DETAILS ON OTHER CONCOMITANT MEDICATIONS BEING USED. THE CONSUMER WAS ASKED IF THE SYMPTOMS IMPROVED AFTER SHE DISCONTINUED USING THE PRODUCT, BUT SHE DID NOT PROVIDE AN ANSWER. AT THE TIME OF REPORTING, SHE WAS STILL EXPERIENCING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506731 NTG LIGHT THERAPY ACNE MASK OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC 70501101247 3506KS04 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention