inforMED
MalfunctionOLP

NTG LIGHT THERAPY ACNE SPOT TREATMENT

Received Oct 3, 2019

Report 2214133-2019-00116 · MDR key 9150357

Device

Generic name

Otc Powered Light Based Laser For Acne

Model number

70501101315

Product problems

  • Smoking
  • Battery Problem
  • Temperature Problem
  • Smoking
  • Battery Problem
  • Temperature Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE SPOT TREATMENT USA 70501101315 7050110131USA 7050110131USA. LOT # IS NOT AVAILABLE. (B)(4). 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 NEUTROGENA LIGHT THERAPY ACNE SPOT TREATMENT. THE CONSUMER ALLEGED THAT THE PRODUCT STARTED TO GET HOT, SMOKE AND THE BATTERY STARTED TO LEAK. CONSUMER STATED THAT SHE SPRAYED THE PRODUCT WITH A MINI FIRE EXTINGUISHER AS A PRECAUTION. THE CONSUMER USED THE PRODUCT FOR TWO DAYS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS EVENT.