BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3883637 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00174
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADDITIONAL INFORMATION REQUESTED VIA EMAIL IN REGARDS TO FOLLOWING: PTS HEIGHT AND WEIGHT. WHAT IS THE MEDICAL HISTORY OF THE PT. HOW LONG WAS PRODUCT IN USE BEFORE THE EVENT OCCURRED. LOT NUMBER. WAS THE PRODUCT USED FOR TREATMENT OR DIAGNOSIS. IS PRODUCT BEING RETURNED. IS COMPLAINT PRODUCT PICTURE AVAILABLE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLY, 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 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 PT HAD FLEXI-SEAL CONTROL PLACED, AND WAS FOUND TO HAVE A RECTAL ULCER AFTER REMOVAL WITH FREE FLOATING RECTUM REQUIRING DIVERTING COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334192 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES, 78 KNT KNT CONVATEC INC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention| S