BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA® LIGHT THERAPY ACNE MASK

    MDR report key: 7336548 · Received March 13, 2018

    Report

    Report Number
    2214133-2018-00002
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 4, 2018
    Report Date
    March 28, 2018
    Manufacturer
    KINSENG PLASTICS CO. LTD.
    Product Code
    OLP
    PMA / PMN Number
    K123999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: ZOFRAN; 2X DAILY; 3 YEARS; TO TREAT GASTRO PARESIS; CONSUMER STILL ON DRUG. DRUG: ERYTHROMYCIN; ½ TAB 3X DAILY; 3 YEARS; TO TREAT GASTRO PARESIS; CONSUMER STILL ON DRUG. DRUG: KEPPRA; 1 TABLET; 4 YEARS; TO TREAT SEIZURES; CONSUMER STILL ON DRUG. DRUG: LAMICTAL; 3 TABLETS; 4 YEARS; TO TREAT SEIZURES; CONSUMER STILL ON DRUG. DEVICE EVALUATION/INVESTIGATION 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED DATE OF MANUFACTURE TO 1/10/2017. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A MOTHER CALLED IN FOR HER (B)(6) YEAR OLD DAUGHTER, WHO HAS BEEN DIAGNOSED WITH AN UNSPECIFIED TYPE OF EPILEPSY, TO REPORT HER DAUGHTER HAS BEEN EXPERIENCING UNUSUALLY FREQUENT SEIZURES WHILE USING THE NTG LIGHT THERAPY ACNE MASK. THE DAUGHTER WAS ADVISED TO CONTINUE TO TAKE HER SEIZURE MEDICATION AT THE REGULAR DOSAGE. DAUGHTER IS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176345 NEUTROGENA® LIGHT THERAPY ACNE MASK ACNE LIGHT THERAPY SYSTEM OLP KINSENG PLASTICS CO. LTD. 070501101247 0107KS04

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention