BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3778193 · Received April 16, 2014

    Report

    Report Number
    2243969-2014-00184
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON T HE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. AN EMAIL HAS BEEN SENT TO THE TERRITORY MANAGER REQUESTING ADDITIONAL INFORMATION WITH ATTACHED QUESTIONAIRE FOR COMPLETION BY NURSE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT PRESENTED WITH A STAGE III PRESSURE ULCER UPON REMOVAL OF AN FMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234149 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention