NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT

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. CORRECTED DATA. EXPIRATION DATE: JANUARY 31,2021. UDI: (B)(4). 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 AUGUST 14,2018. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT 1S EU 3574661383613 3574661383613EUA 3574661383613EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE SPOT TREATMENT USA (B)(4). UDI #: (B)(4), LOT # 2268KS04. 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 SPOT TREATMENT USA (B)(4). 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 TEENAGE CONSUMER OF UNSPECIFIED AGE REPORTED AN EVENT WITH NTG LIGHT THERAPY SPOT ACNE TREATMENT. IT WAS INITIALLY REPORTED THAT SHE DEVELOPED ¿BURNS ON THE LIPS AND EYES AND HAS BEEN UNDER OBSERVATION IN THE HOSPITAL¿. UPON FURTHER INFORMATION, FROM HER PHARMACIST, IT WAS CLARIFIED THAT THE CONSUMER DEVELOPED A ¿ VERY IRRITATED EYES¿ IN THE SCHOOL AND THE MOTHER BROUGHT THE CONSUMER TO EMERGENCY ROOM (ER) AND SHE WAS PLACED ON OBSERVATION. NO FURTHER INFORMATION WAS PROVIDED. THE CONSUMER WAS SUPPOSEDLY LATER TAKEN TO AN OPHTHALMOLOGIST FOR CONSULT AT AN UNSPECIFIED TIME. THERE IS NO INFORMATION ON RESULTS OF ANY DIAGNOSTICS DONE, DIAGNOSIS, TREATMENT AND OUTCOME. THERE WERE NO DETAILS PROVIDED ON THE MEDICAL HISTORY NOR ANY CONCOMITANT MEDICATIONS BEING TAKEN OR DEVICE USAGE SUCH AS FREQUENCY, TIME AND DURATION.