BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU

    MDR report key: 8932303 · Received August 26, 2019

    Report

    Report Number
    2214133-2019-00097
    Event Type
    Injury
    Date Received
    August 26, 2019
    Report Date
    August 28, 2019
    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 · 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. H4, H6: 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. THIS PRODUCT WAS MANUFACTURED ON JUNE 22, 2017. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA). 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 IDENTIFIER, AGE, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA). THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK (B)(4)). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA (B)(4) USB). (B)(4). EXP DATE = NI. LOT NUMBER = (10)1737KS06. (B)(4). THERE IS NO INFORMATION ON THE TIMING AND DURATION OF PRODUCT USE AND ONSET OF THE CONDITION, MEDICAL HISTORY, RESULTS OF ANY DIAGNOSTICS DONE, DIAGNOSIS, TREATMENT AND OUTCOME. 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 EVALUATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. A SUPPLEMENTAL REPORT WILL BE PROVIDED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THERE IS VERY LIMITED INFORMATION TO DETERMINE OR CONCLUDE THAT THE EVENTS MENTIONED IN THE CASE ARE RELATED TO THE DISORDERS OF RETINA (SUCH AS RETINAL DEGENERATION OR OCULAR ALBINISM) IN SUSCEPTIBLE POPULATIONS. ALTHOUGH THERE IS MENTION OF HOSPITALIZATION, THERE IS VERY LIMITED INFORMATION TO CONCLUDE WHETHER THE EVENTS RESULTED IN PERMANENT IMPAIRMENT OR INJURY OR ANY LIFE-THREATENING CONDITION AS THE NATURE OF THE CONDITION IS NOT SPECIFIED AND THERE IS NO INFORMATION ON SPECIFIC TREATMENT AND OUTCOME. 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 MOTHER IN THE UNITED KINGDOM REPORTED ON BEHALF OF HER DAUGHTER AN EVENT WITH THE NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER REPORTED THAT SHE BOUGHT NTG LIGHT THERAPY MASK FOR HER DAUGHTER TO TREAT HER ACNE AND HER DAUGHTER HAS AN UNSPECIFIED EYE PROBLEM ¿CONNECTED WITH ACNE¿ THAT SHE IS IN THE HOSPITAL FOR. THERE IS NO INFORMATION ON THE TIMING AND DURATION OF PRODUCT USE AND ONSET OF THE CONDITION, MEDICAL HISTORY, RESULTS OF ANY DIAGNOSTICS DONE, DIAGNOSIS, TREATMENT AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726036 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU ACNE LIGHT THERAPY SYSTEM OLP JOHNSON & JOHNSON CONSUMER INC. 3574661329499 1737KS06 3574661329499

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization