ON (B)(6) 2018 WAS USED FOR THE DATE OF THE EVENT. THIS WAS REPORTEDLY AN ONGOING ISSUE AND SKIN IRRITATION WAS FIRST REPORTED IN (B)(6). THE LOT NUMBER WAS NOT PROVIDED. WITHOUT A LOT NUMBER, EXPIRATION DATE AND MANUFACTURER DATE COULD NOT BE DETERMINED. (B)(4). THE PATIENT REPORTEDLY CONSULTED A DERMATOLOGIST FOR PATCH TESTING WHICH SHOWED POSITIVE RESULTS FOR ADHESIVES AND ACRYLATES. THE PATIENT REPORTEDLY HAD VERY SENSITIVE SKIN AND WAS USING MULTIPLE ADHESIVE PRODUCTS, OINTMENTS AND CREAMS ON HIS STOMA SITE. THE PATIENT'S REACTION IMPROVED WHEN HE DISCONTINUED ALL PRODUCTS EXCEPT THE OSTOMY POUCH AND USED TRIAMCINOLONE ACETONIDE SPRAY FOR TREATMENT. THIS REPORT WAS SENT TO THE FDA BECAUSE 3M? CAVILON? NO STING BARRIER FILM WAS REPORTEDLY ONE OF THE PRODUCTS USED ON HIS STOMA SITE.
D
Patient 1
A PATIENT'S WIFE REPORTED HER HUSBAND HAD A UROSTOMY CREATED IN (B)(6) 2018. IN (B)(6) HE EXPERIENCED SKIN IRRITATION AROUND HIS STOMA. AN INTERNIST DIAGNOSED THE IRRITATION AS FOLLICULITIS AND PRESCRIBED AN UNSPECIFIED ORAL ANTIBIOTIC. THE IRRITATION IMPROVED UNTIL (B)(6) WHEN THE SKIN AROUND HIS STOMA BECAME BRIGHT RED AND WEEPY. HE WAS REPORTEDLY USING SEVERAL DIFFERENT OSTOMY PRODUCTS AROUND HIS STOMA INCLUDING 3M? CAVILON? NO STING BARRIER FILM, AN OSTOMY POUCH, AN OSTOMY PASTE, OSTOMY GLUE AND BARRIER STRIPS/ RINGS. HE WAS ALSO PERIODICALLY USING OTC OINTMENTS AND CREAMS FOR TREATMENT. HE CONSULTED A DERMATOLOGIST, WAS PATCH TESTED AND SHOWED POSITIVE RESULTS FOR ADHESIVES AND ACRYLATES. HE WAS INSTRUCTED TO USE ONLY WATER FOR CLEANSING AROUND HIS STOMA, TO DISCONTINUE USE OF 3M? CAVILON? NO STING BARRIER FILM AND ALL OTHER OSTOMY PRODUCTS EXCEPT FOR THE OSTOMY POUCH. HE WAS GIVEN A RX FOR TRIAMCINOLONE ACETONIDE SPRAY AND WAS INSTRUCTED TO DISCONTINUE USE OF ALL OTC OINTMENTS AND CREAMS. THE SKIN AROUND HIS OSTOMY HAS REPORTEDLY IMPROVED OVER THE LAST COUPLE OF WEEKS.