BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONVATEC SUREFIT FLEXIBLE NATURA

    MDR report key: 125678 · Received October 10, 1997

    Report

    Report Number
    MW1012278
    Event Type
    Other
    Date Received
    October 10, 1997
    Date of Event
    October 1, 1997
    Report Date
    October 3, 1997
    Manufacturer
    CONVATEC, DIV OF E.R. SQUIDT & SONS, INC.
    Product Code
    EZR
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OSTOMY PROSTHESIS DID NOT ADHERE TO BODY. INEFFECTIVE SEAL CAUSED FECES TO SOIL BODY, THEREBY PREVENTING THE COLOSTOMATE FROM ENGAGING IN NORMAL SOCIAL AND PHYSICAL ACTIVITY. RPTR STATES ITEM IS BEING SENT TO FDA BECAUSE IT IS IMPORTANT THAT FDA KNOWS WHAT A COMPONENT OF A CLASS I PROSTHESIS IS. FLANGE #1-WITHIN 24 HRS THE SEAL SEPARATED AND DID NOT RETAIN THE FECES. FLANGE #2-WITHIN 8 HRS THE SEAL SEPARATED AND DID NOT RETAIN THE FECES. THE NUTRA IS ALLEGED TO BE AN IMPROVED PRODUCT. IT IS NOT AN EFFECTIVE , NOT RELIABLE AND OF A POORER QUALITY THAN ITS PREDECESSOR. SINCE MFR LETTER OF DECEMBER 28,1995, CONVATEC, APPARENTLY, HAD NOT INSTITUTED A QUALITY CONTROL IMPOSSIBLE TO PINPOINT WHY THE ADHERENCE TIME WITH ONE LOT OF PRODUCT WILL VARY FROM THE ADHERENCE TIME OBTAINED WITH A PRODUCT FROM ANOTHER OR THE SAME LOT."THAT, TO ME AND ONE VERSED IN THE ART, SAYS "NO QUALITY CONTROL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVATEC SUREFIT FLEXIBLE NATURA Implant STOMA ADHESIVE FLANGE EZR CONVATEC, DIV OF E.R. SQUIDT & SONS, INC. * 97068531

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 1. OSTOMY POUCH,| 2. CLAMP FOR DRAINAGE APERTURE