NEUTROGENA® LIGHT THERAPY ACNE MASK

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE POWER CORD USED TO CONNECT THE MASK TO THE ACTIVATOR WAS VISIBLY DAMAGED INCLUDING SIGNIFICANT TWISTING OF THE INTERNAL POWER CORDS. THE DAMAGE TO THE CORD APPEARED CONSISTENT WITH THE CONSUMER'S ALLEGATION OF A BURN TO THE CORD. UPON INVESTIGATION OF THE RETURNED PRODUCT, IT WAS NOTED THAT THE PROBABLE CAUSE OF THE BURN WAS AN ELECTRICAL SHORT RESULTING IN HEATING OF THE POWER CONDUCTORS. THE BURNED/DAMAGED SECTION OF THE CORD WAS REMOVED AND THE NON-DAMAGED PORTIONS WERE RE-CONNECTED. ONCE RE-CONNECTED THE CORD WAS ABLE TO POWER THE MASK THROUGH A COMPLETED DOSE WITH NO HEATING OR BURNING OCCURRING. THE POWER CORD FROM A NEW MASK WAS CUT TO COMPARE THE CONDITION OF THE POWER CABLES. IT WAS DETERMINED THAT THE CABLES WERE NOT TWISTED ON A NEW MASK AS THEY WERE ON THE RETURNED MASK SAMPLE AND THEREFORE THE CABLE MAY HAVE UNDERGONE REPETITIVE TWISTING AFTER MANUFACTURING. ADDITIONAL INVESTIGATION IS BEING PERFORMED BY THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS INDICATE THE PRODUCT MET SPECIFICATION AT THE TIME OF RELEASE. BASED ON THE RESULTS OF THE MANUFACTURING INVESTIGATION AND THE EVALUATION OF THE RETURNED SAMPLE, THE DAMAGE TO THE CORD OCCURRING AFTER THE RELEASE OF THE PRODUCT CANNOT BE RULED OUT. 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, WHO IS (B)(6) HAS ALLEGED WHILE USING THE NEUTROGENA LIGHT THERAPY ACNE MASK ON (B)(6) 2018 THAT THE LIGHT MASK CAUGHT ON FIRE. CONSUMER STATED SHE HAD THE ACTIVATOR IN THE POCKET OF HER ROBE AND APPROXIMATELY HALF WAY THROUGH THE 10 MINUTE SESSION, THE CORD STARTED ON FIRE AND BURNED A BIT THROUGH HER ROBE. SHE GRABBED THE CORD TO DISCONNECT IT FROM THE ACTIVATOR AND MASK. SOME OF THE MATERIAL FROM THE CORD STUCK TO HER FINGER. SHE NOTICED THAT SHE HAD A BLISTER ON HER FINGER. CONSUMER DID NOT TREAT THE BLISTER. THE BLISTER ON HER FINGER IS IMPROVING.

Additional Manufacturer Narrative

THE MANUFACTURER MODIFIED A REFERENCE SAMPLE TO CREATE A COMPLETE ELECTRICAL SHORT IN THE POWER CORD. THE DEVICE WITH THE COMPLETE ELECTRICAL SHORT DID NOT FAIL IN THE SAME MANNER AS REPORTED BY THE CONSUMER. THE VOLTAGE FROM THE RETURNED ACTIVATOR AND BATTERIES WERE TESTED AND DETERMINED TO BE WITHIN SPECIFICATION.