NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A5: PATIENT RACE WAS NOT PROVIDED FOR REPORTING. UDI: (B)(4). UPC = (01)70501101247 EXP DATE = (17)200930 LOT NUMBER = (10)3047KS05. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION 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 OCTOBER 31, 2017. (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 THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R RES# (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 FROM A GRANDPARENT WHO REPORTED THAT HER TEENAGE GRANDSON USED THE NTG LIGHT THERAPY ACNE MASK TO TREAT HIS ACNE ONCE A WEEK FOR 10 MINUTES (BETWEEN (B)(6) AND (B)(6) 2019) AND EXPERIENCED MIGRAINES AT AN UNSPECIFIED TIME WITHIN 6 TO 8 HOURS OF USING THE PRODUCT. THE CONSUMER CONSULTED WITH A HEALTH CARE PROFESSIONAL WHO RECOMMENDED TREATMENT WITH UNSPECIFIED DOSES OF PROPRANOLOL. THERE WERE NO DIAGNOSTICS/ LABORATORY WORKUPS DONE. THE GRANDMOTHER MENTIONED THAT THE SYMPTOMS IMPROVED WHEN THE CONSUMER DISCONTINUED USING THE PRODUCT AT AN UNSPECIFIED TIME AND AS OF (B)(6) 2019, THE CONSUMER WAS NO LONGER EXPERIENCING THE SYMPTOMS.