NTG LIGHT THERAPY ACNE MASK
Received Dec 3, 2019
Report 2214133-2019-00134 · MDR key 9404988
Device
Generic name
Acne Light Therapy System
Manufacturer
Johnson & Johnson Consumer IncModel number
70501101247Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, SEX, WEIGHT, ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB. LOT # IS NOT AVAILABLE. UDI # (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. AT THIS TIME, WITH LIMITED INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. (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 CONSUMER REPORTED AN EVENT WITH NEUTROGENA LIGHT THERAPY ACNE MASK. THE CONSUMER USED THE LIGHT THERAPY MASK TO TREAT ACNE FOR AN UNKNOWN FREQUENCY AND DURATION AND REPORTED NOTICING THAT HIS/HER EYES WERE ¿EASILY IRRITATED¿. THE CONSUMER STOPPED USING THE PRODUCT, DUE TO THE IRRITATION AND THAT HIS/HER ACNE CLEARED. THE CONSUMER STARTED USING THE PRODUCT AGAIN AND NOTICED THAT THE EYES BECAME IRRITATED. THE CONSUMER MENTIONED HAVING ¿SENSITIVE¿ SKIN BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE CONSUMER VISITED PHYSICIANS WHO SUPPOSEDLY SAW ¿IRRITATION¿ AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR AN UNSPECIFIED INDICATION. THERE IS NO INFORMATION ON ANY DIAGNOSTICS DONE, THE DIAGNOSIS, TREATMENT AND OUTCOME.