NEUTROGENA LIGHT THERAPY ACNE MASK KIT AP 0443AP
Received Aug 26, 2019 · Event occurred Oct 11, 2018
Report 2214133-2019-00094 · MDR key 8930166
Device
Generic name
Acne Light Therapy System
Manufacturer
Johnson & Johnson Consumer IncModel number
26202031BProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Headache
- Loss of Vision
- Headache
- Loss of Vision
Narrative
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 (NEUTROGENA LIGHT THERAPY ACNE MASK AP 26202031B 0026202031APB). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK KIT USA (B)(4)). LOT NUMBER IS NOT AVAILABLE. (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). 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. A SUPPLEMENTAL REPORT WILL BE PROVIDED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THERE IS VERY LIMITED INFORMATION TO DETERMINE OR CONCLUDE 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
AN (B)(6) FEMALE CONSUMER REPORTED AN EVENT WHILE USING THE NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER, OF UNSPECIFIED AGE, USED THE NEUTROGENA LIGHT THERAPY ACNE MASK FOR HER ACNE 3-4 TIMES A WEEK FOR 10 MINUTES PER SESSIONS (STARTING (B)(6) 2018) AND AFTER APPROXIMATELY 3 WEEKS ((B)(6) 2018) SHE WOKE UP WITH 10 PERCENT VISION IN HER EYE. SHE WAS ADMITTED IN A HOSPITAL WHERE SHE UNDERWENT MRI SCANS AND SHE WAS DIAGNOSED WITH ¿UNEXPLAINED MIGRAINES¿. THE CONSUMER IS STILL EXPERIENCING THE SYMPTOMS. THE CASE NECESSITATED HOSPITALIZATION BUT THERE ARE NO DETAILS ON THE DESCRIPTION OF THE VISUAL IMPAIRMENT/SYMPTOMS AND DURATION, ACCOMPANYING SIGNS AND SYMPTOMS, RESULTS OF EXAMINATIONS, TREATMENT AND THE OUTCOME. THERE ARE NO DETAILS ON VISUAL IMPAIRMENT OR SYMPTOMS. INFORMATION ON MEDICAL HISTORY, ANY CONCOMITANT MEDICATIONS AND RESULTS OF EXAMINATION OR DIAGNOSTICS DONE, TREATMENTS AND THE OUTCOME ARE NOT AVAILABLE.