EAKIN COHESIVE SEALS

Description of Event or Problem

REPORTED BY THE COMPLAINANT AS FOLLOWS... COMPLAINT RECEIVED BY (B)(4), ALSO APPLIES FOR (B)(4) LOT 1L02643. STARTING BACK IN (B)(6) 2012 (B)(6) DEVELOPED AN ULCER IN THE PERISTOMAL AREA AT ABOUT 3 O'CLOCK. IT IS ABOUT 1 CM X 2 CM X 0.2 CM WITH RED MOIST WD BED AND RED TO PURPLISH EDGES. SHE HAS BEEN SEEN BY HER DERMATOLOGIST DR (B)(6) WHO IS REQUESTING THE INGREDIENTS IN BOTH EAKIN SEAL AND SH STRIP. AS SHE SUSPECTS AN ALLERGIC REACTION. MEDICAL TX HAS SEEN DERMATOLOGIST WHO SUSPECTS PYODERMA GRANULOSUM ULCER WAS INJECTED WITH STEROIDS 2 WEEKS AGO AND (B)(6) APPLIES CLOMEX SPRAY AT EACH POUCH CHANGE ABOUT Q4DAYS. MEDICAL HX COLOSTOMY FOR PERF DIVERTIC (B)(4) VASCULITIS BLE ABOUT 1 YR AGO. ARTHRITIS MEDS. TAKES OTC MEDICATIONS FOR ARTHRITIS. ALLERGIES: LIDOCAINE ADHESIVE TAPE GOLD ENVIRONMENTAL.

Additional Manufacturer Narrative

THE MEDICAL DETERMINATION IS 'SERIOUS' BECAUSE OF THE MENTION IN THE COMPLAINT NARRATIVE THAT THE SUSPECTED DIAGNOSIS IS: 'PYODERMA GANGRENOSUM'. PYODERMA GANGRENOSUM IS AN UNCOMMON, ULCERATIVE CUTANEOUS CONDITION OF UNCERTAIN ETIOLOGY. IT IS ASSOCIATED WITH SYSTEMIC DISEASES IN AT LEAST 50% OF PATIENTS WHO ARE AFFECTED. THE DIAGNOSIS IS MADE BY EXCLUDING OTHER CAUSES OF SIMILAR-APPEARING CUTANEOUS ULCERATIONS, INCLUDING INFECTION, MALIGNANCY, VASCULITIS, COLLAGEN VASCULAR DISEASES, DIABETES, AND TRAUMA. IN A PROCESS TERMED PATHERGY, NEW ULCERATIONS MAY OCCUR AFTER TRAUMA OR INJURY TO THE SKIN IN 30% OF PATIENT WHO ALREADY HAVE PYODERMA GANGRENOSUM. (CULLED FROM A MEDSCAPE ARTICLE). IT IS UNLIKELY THAT TRAUMA TO THE SKIN FROM THE EAKIN COHESIVE SEALS/SKIN BARRIER HAS LED TO THIS CONDITION. A MORE BIOLOGICALLY PLAUSIBLE EXPLANATION FOR THIS EVENT IS THE FACT THAT THE PATIENT WAS REPORTED TO HAVE BEEN TREATED LAST YEAR FOR VASCULITIS (A SYSTEMIC MEDICAL CONDITION THAT CAN GIVE SIMILAR SKIN SYMPTOMS AS PYODERMA GANGRENOSUM). REPORTED TO THE FDA ON (B)(4) 2013. THIRD PARTY MANUFACTURER - (B)(4).