[49985096]
Initial information was received on 04/28/2016 and was processed with additional information received on 06/13/2016. The case has been reassessed as serious based upon new information received on 06/13/2016. This spontaneous report was received on 04/28/2016 from a (b)(6) caucasian female consumer reporting on self from the united states of america. The medical history included seasonal allergies. The concomitant medications included generic zyrtec (cetirizine) one tab daily since three weeks for season allergies. The reported weight of the consumer was 52 kilograms. On (b)(6) 2018, the consumer started using neutrogena naturals fresh cleansing makeup remover topically, nickle size amount, at night used twice to clean the face (lot number 0095lk and expiration date unspecified) with clarisonic (wrong technique in product usage process) topically to clean the face (frequency, lot number and expiration date unspecified). On the next morning, the consumer developed swelling on face. She reported that, the product did not agree with her skin and she felt uncomfortable. On the same day, the consumer again used the product in night and on the next day,she woke up with a very swollen, warm face which consumer described as felt like sunburn. The product was not used further. She said that her face feels better but looks worse. She treated the swelling with a double dose of an antihistamine. On (b)(6) 2016, the consumer consulted healthcare professional and was diagnosed with allergic dermatitis and prescribed with dapomedrol (methylprednisolone) 40 mg/ml injection and hydrocortisone 2. 5 percent creams. The consumer stated that she usually purchased the product without make up remover but accidentally purchased this product with makeup remover (wrong product selected). The action taken with the clarisonic was unknown. On (b)(6) 2016, all the events resolved. This report was assessed as serious (medically significant) and company causality was assessed as possible. Dose: nickel size, twice, topical. Therapy dates: (b)(6) 2016. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5