NTG LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. (B)(4). EXPIRATION DATE= NI, LOT NUMBER = (10)3367KS05. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: METROPROLOL ; 2X DAILY AND 2 PILLS; HAS TAKEN DRUG SINCE 19 YEARS OLD; CONSUMER STILL ON DRUG. DRUG: KEPPRA; 2X DAILY (ONE PILL IN MORNING AND HALF IN AFTERNOON); 5 YEARS; 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.

Description of Event or Problem

A FEMALE CONSUMER REPORTED AN EVENT WITH THE NTG LIGHT THERAPY ACNE MASK. THE CONSUMER STATED THAT SHE HAS A HISTORY OF EPILEPSY, DIFFERENT KINDS OF SEIZURES AND TRAUMATIC BRAIN PROBLEMS. THE CONSUMER STATED THAT THE PRODUCT CAUSED HER TO HAVE MULTIPLE, MINOR SEIZURES. THE CONSUMER WAS USING THE PRODUCT DAILY FOR 10-MINUTE TREATMENTS TO TREAT HER ECZEMA. HER FIRST USE STARTED ON (B)(6) 2019 AND HER LAST USE WAS (B)(6) 2019. THE CONSUMER¿S SYMPTOMS BEGAN (B)(6) 2019. THE SYMPTOMS IMPROVED AFTER THE CONSUMER STOPPED USING THE PRODUCT. THE CONSUMER ATTEMPTED TO RE-USE THE PRODUCT AND THE SYMPTOMS REAPPEARED. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION BUT CONTINUED TO TAKE HER SEIZURE MEDICATION. THE CONSUMER STOPPED EXPERIENCING ANY SYMPTOMS.

Additional Manufacturer Narrative

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 DECEMBER 2, 2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.