BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3862763 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00151
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 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 INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATED IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIRD PARTY MANUFACTURING SITE: (B)(4). 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 WHILE RN WAS SPEAKING TO THE STAFF WHEN THE FACILITY MADE THE TRANSFER FROM SIGNAL TO CONTROL LATE LAST YEAR AND EARLY 2014, SHE RECALLED A PATIENT WHO DEVELOPED A RECTAL PRESSURE ULCER DURING USE OF AN FMS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311803 FLEXI-SEAL CONTROL FMS KIT US 78 KNT KNT CONVATEC INC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention