NEUTROGENA® LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: ZOFRAN; 2X DAILY; 3 YEARS; TO TREAT GASTRO PARESIS; CONSUMER STILL ON DRUG. DRUG: ERYTHROMYCIN; ½ TAB 3X DAILY; 3 YEARS; TO TREAT GASTRO PARESIS; CONSUMER STILL ON DRUG. DRUG: KEPPRA; 1 TABLET; 4 YEARS; TO TREAT SEIZURES; CONSUMER STILL ON DRUG. DRUG: LAMICTAL; 3 TABLETS; 4 YEARS; TO TREAT SEIZURES; 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 MOTHER CALLED IN FOR HER (B)(6) YEAR OLD DAUGHTER, WHO HAS BEEN DIAGNOSED WITH AN UNSPECIFIED TYPE OF EPILEPSY, TO REPORT HER DAUGHTER HAS BEEN EXPERIENCING UNUSUALLY FREQUENT SEIZURES WHILE USING THE NTG LIGHT THERAPY ACNE MASK. THE DAUGHTER WAS ADVISED TO CONTINUE TO TAKE HER SEIZURE MEDICATION AT THE REGULAR DOSAGE. DAUGHTER IS FEELING WELL.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED DATE OF MANUFACTURE TO 1/10/2017. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.