NEUTROGENA LIGHT THERAPY ACNE MASK KIT AP 0443AP

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT, AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ((B)(6) ACNE MASK AP 26202031B 0026202031APB). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA ((B)(6) ACNE MASK KIT USA 70501101247 7050110124USA 7050110124USA). (B)(4). EXPIRATION DATE= NI LOT NUMBER = NI. 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). (B)(4). DEVICE EVALUATION/INVESTIGATION 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. A SUPPLEMENTAL REPORT WILL BE PROVIDED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. THERE IS VERY LIMITED INFORMATION TO DETERMINE OR CONCLUDE THAT PRODUCT USE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EVENTS OR THAT THE EVENTS MENTIONED IN THE CASE ARE RELATED TO THE DISORDERS OF RETINA (SUCH AS RETINAL DEGENERATION OR OCULAR ALBINISM) IN SUSCEPTIBLE POPULATIONS. 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 MALE CONSUMER REPORTED AN EVENT WITH (B)(6) ACNE MASK. THE EVENT WAS RECEIVED FROM CONSUMER OF UNKNOWN AGE WHO CALLED TO REPORT THAT HE USED THE (B)(6) ACNE MASK FOR AN UNSPECIFIED TIME AND DURATION AND HAD BEEN GOING TO THE HOSPITAL FOR CONSTANT MIGRAINES. THE CONSUMER VISITED A NEUROLOGIST DAILY AND UNDERWENT A LUMBAR TAP. THERE ARE NO DETAILS ON THE DESCRIPTION OF THE SIGN AND SYMPTOMS, ONSET AND DURATION. INFORMATION ON THE MEDICAL HISTORY, ANY CONCOMITANT MEDICATIONS AND RESULTS OF THE EXAMINATIONS OR DIAGNOSTICS DONE, TREATMENTS ARE NOT AVAILABLE. ACCORDING TO THE CONSUMER, A COUPLE OF MONTHS UPON PRODUCT DISCONTINUATION, THE MIGRAINES STOPPED. IN ADDITION, CONSUMER HAS DEVELOPED ANXIETY AND HAS PAIN DUE TO THIS EVENT.