BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3761025 · Received April 11, 2014

    Report

    Report Number
    2243969-2014-00182
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT MANAGER HAS EMAILED A FMS QUESTIONNAIRE TO NURSE ON (B)(4) 2014, AND AN APPOINTMENT TO VISIT NURSE ON (B)(4) 2014. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO 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. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT DEVELOPED A PRESSURE ULCER WHILE USING THE FMS CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221359 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES, 78 KNT KNT CONVATEC INC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention