NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT
Received Jan 11, 2019
Report 2214133-2019-00059 · MDR key 8238764
Device
Generic name
Otc Powered Light Based Laser For Acne
Manufacturer
Johnson & Johnson Consumer IncModel number
6907376834465Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Reaction
- Reaction
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, SEX, WEIGHT AND ETHNICITY AND RACE 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 SPOT TREATMENT USA 70501101315). THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT AP 6907376834465, 26202392APA, 26202392APA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315). (B)(4). 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 SPOT TREATMENT USA 70501101315). 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
IT WAS REPORTED THAT THE CONSUMER EXPERIENCED AN ALLERGY AFTER USING THE NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. THE CONSUMER SOUGHT MEDICAL ATTENTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED OR RECEIVED.