NEUTROGENA® LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: KLONOPIN; AS NEED; 2-3 YEARS; TO TREAT PANIC; ANXIETY DISORDER; CONSUMER STILL ON DRUG: WELLBUTRIN; 1X DAILY; 2-5 YEARS; TO TREAT DEPRESSION; CONSUMER STILL ON DRUG. (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

CONSUMER REPORTED THAT AFTER USING THE ACNE MASK SHE EXPERIENCED SPLOTCHES, RASH, SORES, WELTS, INFLAMED RED BLOTCHES AND LARGE PAINFUL BUMPS THAT COVERED HER FACE AND NECK. CONSUMER WAS IN PAIN FROM THE OUTBREAK AND CLAIMS THAT THE MASK BURNED AND WRINKLED HER SKIN AND CAUSED MULTIPLE LINES ON HER FOREHEAD. CONSUMER EXPERIENCED DEPRESSION SINCE USE OF THE MASK. CONSUMER IS RECOVERING BUT STILL HAS A RASH AND BUMPS ON HER FACE AND NECK.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. DATE OF MANUFACTURE WAS UPDATED TO 01 AUG 2016. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS FOLLOW-UP MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.