Angelini pharma inc.Was received a complaint filled with (b)(4) about an adverse event involving alcavis 50.On march 1st, (b)(4) was contacted by the patient about an incident that happened on (b)(6) 2017.The patient stated that while using alcavis 50 to clean the catheter while preparing for his peritoneal dialysis, he spilled alcavis 50 on his underpants.He did not notice that his underwear was wet and went to bed with the wet garments.In the next morning, he felt that the genital area was uncomfortable and noticed his underpants was discolored.He then realized that he had spilled alcavis 50 on himself and went to bed without exchange it.He noticed that the genitals were reddish and sensitive; he then showered and washed the affected area with antimicrobial soap, treated with hydrogen peroxide, and with triple antibiotic ointment.Two/three days later, he had a visit with his nephrologist who referred him to the primary doctor, and this to his urologist.With the urologist, he began treatment with lidocaine gel (4%) and clotrimazole and betamethasone dipropionate cream.Region is still having an open would and is still painful.Patient is diabetic and undergoes hyperbaric treatment.Patient continues using alcavis 50.
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