BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAHESIVE WAFER WITH CONVEX-IT

    MDR report key: 597587 · Received April 30, 2005

    Report

    Report Number
    1049092-2005-00017
    Event Type
    Other
    Date Received
    April 30, 2005
    Date of Event
    May 25, 1997
    Report Date
    April 29, 2005
    Manufacturer
    CONVATEC
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER APPLIED THE DURAHESIVE WAFER WITH CONVEX-IT IN 1997 AND WORE IT UNTIL 5 DAYS WITHOUT ANY DIFFICULTY OR DISCOMFORT. SKIN WAS CLEAR WHEN THEY REMOVED THE WAFER AND THEN APPLIED A SECOND WAFER ON THE SAME DAY. FOUR DAYS LATER THE CUSTOMER NOTED BLOOD TINGED URINE WHICH CONTINUED UNITL EVENT DATE. THE CUSTOMER ALMOST SOUGHT MEDICAL ATTENTION AT LOCAL ER FOR THE BLOOD TINGED URINE IN POUCH. SMALL AREA AT THE BASE OF THE STOMA (AT LINE WHERE SKIN MEETS THE STOMA) WAS ULCERATED, THIS WAS CAUTERIZED AND TWO DISSOLVING SUTURES WERE PLACED IN THE ULCER. PATIENT WAS SWITCHED TO DURAHESIVE LOW PROFILE WAFER AND FIVE DAYS LATER ULCER HEALED. PATIENT STATED THAT THEY LIKE THE DURAHESIVE WAFER WITH CONVEX-IT AND WOULD LIKE TO RESUME USE. SUGGESTED THAT INDIVUDUAL CONTACT LOCAL RNET PRIOR TO RESUMING USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAHESIVE WAFER WITH CONVEX-IT OSTOMY APPLIANCE EXB CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other