NTG LIGHT THERAPY ACNE MASK

Description of Event or Problem

THIS CASE WAS RECEIVED FROM A FEMALE CONSUMER WHO INQUIRED ABOUT GETTING A PRODUCT REFUND AND MENTIONED THAT SHE STARTED USING NTG LIGHT THERAPY MASK ON (B)(6) 2018 FOR ACNE 3 TIMES A WEEK. SHE MENTIONED THAT SHE EXPERIENCED HAVING HEADACHES WHICH SHE INITIALLY ATTRIBUTED TO THE UNSPECIFIED CONCOMITANT MEDICATION THAT SHE WAS TAKING AT THE TIME. SHE CONSULTED WITH AN HEALTH CARE PROFESSIONAL (HCP) WHO RECOMMENDED USE OF UNSPECIFIED DOSES OF KETOROLAC (TORADOL) AND ADVISED DISCONTINUATION OF PRODUCT USE. ACCORDING TO THE CONSUMER, SHE STOPPED USING THE PRODUCT AT AN UNSPECIFIED TIME AND THE CONDITION RESOLVED ON (B)(6) 2018. THE CONSUMER IS NOT EXPERIENCING ANY SYMPTOMS WHILE REPORTING THIS EVENT. THERE IS NO INFORMATION ON ANY TESTS/ EXAMINATIONS THAT WERE CONDUCTED AND THE RESULTS AND THE DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION ON THE CONCOMITANT MEDICATION THAT THE CONSUMER MENTIONED. THERE IS ALSO NO INFORMATION ON HER MEDICAL HISTORY.

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 AND 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. A2, A4, A5: AGE: 32 YEARS OLD; PATIENT WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB, LOT NUMBER 3297KS05. D4: UDI #: (B)(4). UPC #70501101247. LOT #: 3297KS05. EXPIRATION DATE - OCTOBER 31, 2020. D10: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. WHILE HEADACHE ASSOCIATED WITH USE OF NEUTROGENA LIGHT THERAPY ACNE MASK MAY POSSIBLY BE CAUSED BY GLARE FROM THE LIGHTS, WHERE UNDERLYING REFRACTIVE OR ACCOMMODATIVE ERRORS MAY INCREASE SENSITIVITY, IT IS LIKELY TO BE MILD AND TRANSIENT. BASED ON THE LIMITED INFORMATION AVAILABLE, THE HEADACHE RESOLVED AFTER ONE MONTH. FURTHER ANALYSIS OF THIS CASE MAY BE CONFOUNDED BY THE INTAKE OF A CONCOMITANT MEDICATION. 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: (B)(4) ). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

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. H3,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. THE PRODUCT WAS MANUFACTURED ON NOVEMBER 25, 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.