NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, SEX, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE SPOT TREATMENT USA (B)(4). LOT # IS NOT AVAILABLE. (B)(4), EXPIRATION DATE= NI, LOT NUMBER = NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. (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

A CONSUMER REPORTED AN INCIDENT AFTER USING THE NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. CONSUMER HAS BEEN USING THE DEVICE FOR TWO DAYS FOR HIS/HER PIGMENT; HOWEVER, THE CONSUMER ALLEGED IT HAS ONLY MADE IT WORSE. CONSUMER STATES THAT HIS/HER SKIN IS EVEN MORE DRY AND RED AND BURNS. THE CONSUMER ALSO STATES THAT HE/SHE HAS BEEN HAVING SEVERE HEADACHES. CONSUMER'S DERMATOLOGIST HAS BEEN GIVING THE CONSUMER MULTIPLE PRESCRIPTIONS AND THE SYMPTOMS HAVE NOT RESOLVED. CONSUMER STATES THAT HIS/HER FACE IS GETTING WORSE.