BEUDAMED
    FDA Adverse Event Death Summary report: N

    NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB

    MDR report key: 7878668 · Received September 14, 2018

    Report

    Report Number
    2214133-2018-00046
    Event Type
    Death
    Date Received
    September 14, 2018
    Date of Event
    August 16, 2018
    Report Date
    August 16, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA (B)(4), LOT # IS NOT AVAILABLE. UDI # (B)(4), UPC = (B)(4), EXPIRATION DATE= NI, LOT NUMBER = NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, 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. LABELING STATES DO NOT USE LIGHT THERAPY ACNE MASK IF YOU ARE PREGNANT, MAYBE PREGNANT, OR NURSING AS THE RISKS ARE UNKNOWN AND HAVE NOT BEEN ESTABLISHED. 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 HUSBAND REPORTED THAT ON (B)(6) 2018 HIS WIFE HAD 2 POSITIVE PREGNANCY TESTS. CONSUMER HAD BEEN USING PRODUCT IN THE PAST WEEKS WHILE PREGNANT, EXPECTED DUE DATE (B)(6) 2019. ON (B)(6) 2018 CONSUMER SUFFERED A MISCARRIAGE DUE TO ECTOPIC PREGNANCY AND UNDERWENT SURGERY TO CORRECT IT ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719835 NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC 70501101247

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death