BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMS - FECAL MANAGEMENT SYSTEM

    MDR report key: 4101742 · Received September 15, 2014

    Report

    Report Number
    1049092-2014-00466
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. PER THE COMPLAINT, FLUID IS NOT BEING PROPERLY CHECKED IN THE BALLOONS WHICH LEADS TO A BALLOON WITH FLUID AND AIR. TRAINING WAS TO BE SCHEDULED BY THER USER FACILITY TO EDUCATE ON THE PROPER USE OF THE PRODUCT AND IRRIGATIONS. FOUR ADDITIONAL ATTEMPTS FOR INFORMATION HAVE BEEN REQUESTED, HOWEVER, NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT DEVELOPED A PRESSURE ULCER IN THE RECTAL VAULT WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569619 FMS - FECAL MANAGEMENT SYSTEM GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1