NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU
Received May 24, 2018 · Event occurred Sep 30, 2017
Report 2214133-2018-00007 · MDR key 7541221
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR
- Visual Impairment
- No Code Available
- Visual Impairment
- No Code Available
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. 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). LOT # WAS NOT PROVIDED. 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. 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 CALLED ABOUT THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK SHE WAS USING FOR ACNE TREATMENT. THE CONSUMER STARTED USING THE DEVICE ON (B)(6) 2017 FOR DAILY TREATMENT. SINCE (B)(6) 2017 SHE IS ALLEGING THAT HER EYES HAVE BEEN DRY AND THAT SHE IS SENSITIVE TO THE SUNLIGHT. CONSUMER WAS SEEN BY A HEALTH CARE PROFESSIONAL WHO PRESCRIBED CORTISONE FOR TREATMENT. CONSUMER HAS ALSO BEEN USING A TEAR SUBSTITUTE FOR 2-3 MONTHS. CONSUMER IS ALLEGING DAMAGE TO THE CORNEAS AND SYMPTOMS ASSOCIATED WITH THE DISEASE SICCA (DRY EYES). SYMPTOMS HAVE NOT RESOLVED.