NEUTROGENA LIGHT THERAPY ACNE MASK AP

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 (B)(4)). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK 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/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. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. BASED ON THE AVAILABLE DATA AND ETIOLOGY, THERE IS NO INFORMATION AND MECHANISM TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN CELLULITIS AND PRODUCT USE. ALTHOUGH THE TYPE OF CELLULITIS IS NOT SPECIFIED IN THE CASE, TREATMENT WITH ANTIBIOTICS WAS NECESSARY WITH SEVERAL FOLLOW-UPS. APPROPRIATE TREATMENT IS GIVEN TO PATIENTS TO PREVENT SERIOUS COMPLICATIONS OR INJURY ESPECIALLY FOR ORBITAL CELLULITIS. GIVEN THE DIAGNOSIS OF CELLULITIS, THIS IS NOT LIKELY TO BE RELATED TO THE RETINAL DISORDERS (SUCH AS RETINITIS PIGMENTOSA, OCULAR ALBINISM) IN THE SUSCEPTIBLE POPULATION. (B)(4). 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 OF UNKNOWN AGE USED THE NEUTROGENA LIGHT THERAPY ACNE MASK FOR UNKNOWN TIME AND DURATION AND REPORTED THAT SHE DEVELOPED A HUGE CYST IN HER LEFT EYE THAT TURNED INTO CELLULITIS. THE CONSUMER SOUGHT MEDICAL ATTENTION AND SHE WAS GIVEN AN UNSPECIFIED STRONGEST ANTIBIOTIC AND AT THE TIME OF THE REPORT, SHE WAS VISITING THE DOCTOR FOR THE THIRD TIME. THERE ARE NO DETAILS ON THE FINDINGS, LABORATORY OR EXAMINATIONS DONE, SPECIFIC TREATMENT GIVEN AND OUTCOME. THERE IS NO INFORMATION ON MEDICAL HISTORY.