BEUDAMED
    FDA Adverse Event Summary report: N

    STOMAHESIVE STRIPS

    MDR report key: 2967992 · Received February 13, 2013

    Report

    Report Number
    2243969-2013-00007
    Date Received
    February 13, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CONVATEC
    Product Code
    EZR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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). (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS... COMPLAINT RECEIVED BY (B)(4) TEAM, ALSO APPLIES FOR 025542 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)(6) VASCULITIS BLE ABOUT 1 YR AGO. ARTHRITIS MEDS SEE ABOVE CLOMEX SPRAY TAKES OTC MEDICATIONS FOR ARTHRITIS ALLERGIES LIDOCAINE ADHESIVE TAPE GOLD ENVIRONMENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63863 STOMAHESIVE STRIPS PROTECTOR/OSTOMY EZR CONVATEC NA 1L02643

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention