NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, 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 EU 3574661359182). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK KIT USA 70501101247 7050110124USA 7050110124USA). UPC = (B)(4). EXP DATE = (17)201231. LOT NUMBER = (10)0168KS06. UDI: (B)(4). 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 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 JANUARY 16, 2018. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. (B)(4). THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: (B)(4).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.

Description of Event or Problem

THIS CASE WAS RECEIVED FROM A MOTHER WHO VISITED A PHARMACY TO BUY A REPLACEMENT AND LEARNED ABOUT THE RECALL AND THEN REPORTED THAT HER (B)(6) YEAR OLD SON USED THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU FOR MILD ACNE DAILY (5 TIMES WEEK ACCORDING TO THE INSTRUCTIONS FOR USE) STARTING AT AN UNSPECIFIED DATE UNTIL (B)(6) 2019 (FOR APPROXIMATELY 10 SESSIONS) AND MENTIONED THAT PRODUCT ¿COULD HAVE DONE EYE DAMAGE¿ AND ¿POSSIBLY AN EYE HERPES¿ ON HER SON. SHE SAID THAT IN (B)(6) 2019, HER SON DEVELOPED ¿OCULAR HERPES¿ ON TOP OF THE UPPER EYELID AND HE STOPPED USING THE MASK AFTER A MONTH AND STARTED USING THIS AGAIN AT AN UNSPECIFIED TIME. UPON CONSULTATION WITH AN HCP, THE CONSUMER WAS DIAGNOSED WITH ¿EYE HERPES¿ (¿WITH NO EYE DAMAGE¿) AND HE WAS PRESCRIBED WITH CHLORHEXIDINE GLUCONATE (CRISTALMINA), A DISINFECTANT AND ACYCLOVIR (ZOVIRAX OCULAR), AN ANTI-VIRAL MEDICATION. THE ROUTES, PREPARATIONS AND DOSAGES OF BOTH MEDICATIONS WERE NOT SPECIFIED. THERE WERE NO LABORATORY TESTS OR WORK-UPS DONE. ACCORDING TO THE MOTHER, HER SON RECOVERED AND WAS NO LONGER EXPERIENCING THE SYMPTOMS (SINCE (B)(6) 2019). THE MOTHER ALSO STATED HER SON ALSO EXPERIENCED HEADACHE AND DIZZINESS TWO TIMES SINCE SEPTEMBER WHEN HE WOKE UP IN THE MORNING BUT THIS WAS NOT AFTER USING THE MASK.