inforMED
InjuryOLP

NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

Received Sep 22, 2020 · Event occurred Apr 28, 2018

Report 2214133-2020-00035 · MDR key 10565917

Device

Generic name

Acne Light Therapy System Otc

Model number

3574661329499

Lot number

1707KS06

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Headache
  • Headache

Narrative

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AT TIME OF EVENT, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU 3574661329499 LTCMA11827EUA LTCMA11827EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB). UDI: (B)(4). UPC = (01)3574661329499, EXP DATE = (17)200531, LOT NUMBER = (10)1707KS06. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON JUNE 19, 2017. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION OF AN INVESTIGATION TO DETERMINE IF THE DEVICE IS ASSOCIATED WITH THIS EVENT. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: 2214133-04/24/2019-001-R RES# 83291). 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

THIS CASE WAS RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE WHO REPORTED USING NTG VISIBLY CLEAR LIGHT THERAPY MASK DAILY FOR 2 MONTHS (FROM (B)(6) 2018 TO (B)(6) 2018) FOR ACNE. AFTER APPROXIMATELY 1 MONTH OF PRODUCT USE ((B)(6) 2018), SHE EXPERIENCED ¿HEADACHES/ VERY BAD MIGRAINES¿. SHE VISITED THE DOCTOR AND WAS TREATED WITH UNSPECIFIED PAINKILLERS OF UNSPECIFIED DOSAGES AND ONGOING REVIEW. THERE IS NO INFORMATION ON CONCOMITANT DISEASES, CONCOMITANT MEDICATIONS BEING TAKEN OR MEDICAL HISTORY. THERE ARE NO DETAILS ON CONSULTATIONS, ANY EXAMINATIONS CONDUCTED/ THE RESULTS OF WHICH OR THE DIAGNOSIS. THE CONSUMER MENTIONED THAT UPON DISCONTINUATION OF PRODUCT USE, THERE WAS RESOLUTION OF THE CONDITION.