NTG LIGHT THERAPY ACNE MASK USA
Received Nov 22, 2019
Report 2214133-2019-00131 · MDR key 9365252
Device
Generic name
Acne Light Therapy System
Manufacturer
Johnson & Johnson Consumer IncModel number
70501101247Product problems
- Smoking
- Smoking
Patient
Not reported
- Not Applicable
- Not Applicable
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247, 7050110124USB. LOT # IS NOT AVAILABLE. UDI # (B)(4); LOT NUMBER = NI; EXP DATE: 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. 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 FEMALE CONSUMER REPORTED AN EVENT WITH THE NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER REPORTED THAT WHEN SHE TRIED TO OPEN IT, THE LIGHTS FLASHED FOR JUST A MINUTE AND IT STARTED TO SMOKE A LITTLE BIT. THERE WAS NO ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.