BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 4024609 · Received August 1, 2014

    Report

    Report Number
    1049092-2014-00386
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 20, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Removal / Correction Number
    Z-1785-2014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO THE FDA ON AUGUST 01, 2014. 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 THE PT WHO WAS ON A LOW AIR MATTRESS AT TIME DUE TO REPAIRED PHYSICAL MOBILITY RESULTING FROM HIS LEFT HIP REVISION SURGERY, DEVELOPED A STAGE III PRESSURE ULCER WITH SLOUGH/NECROTIC TISSUE '3.0 X 2.0 X 0.1 CMS' COVERED BASE DISTAL TO THE ANUS ASSOCIATED WITH PROLONGED PRESSURE ON TISSUE FROM FMS TUBES AFTER TWENTY (20) DAYS INSITU. IT IS FURTHER REPORTED THAT THE FMS WAS INSERTED FILLED WITH 45ML ON (B)(6) 2014 RELATED TO THE LARGE AMOUNTS OF LIQUID STOOL, AND REMOVED ON (B)(6) 2014 RELATED TO STOOL SOLIDIFYING. LASTLY, IT IS REPORTED THAT INTERVENTIONS CARRIED OUT TO TREAT THIS ISSUE WAS OFF-LOADING AND DRESSING; IN ADDITION THE PT IS STABLE REQUIRING ONGOING TREATMENT AND WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451695 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES, 78 KNT KNT CONVATEC, INC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention